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To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

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ClinicalTrials.gov Identifier: NCT00754065
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : August 28, 2012
Last Update Posted : July 19, 2013
Sponsor:
Information provided by:
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Contraception
Interventions Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Ortho Tri Cyclen Lo
Enrollment 409
Recruitment Details The date of first subject first visit was 08 Sep 2008. The date of last subject last visit was 10 May 2011.
Pre-assignment Details A total of 776 participants were screened; 367 failed Screening, and 409 were randomized 1:1, of which 14 never received treatment, and 395 were treated (EV/DNG=191; EE/NGM=204). A total of 203 subjects (99 received EV/DNG and 104 EE/NGM) in the US and 192 (92 received EV/DNG and 100 EE/NGM) in Canada received at least one dose of the study drug.
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Period Title: Overall Study
Started 203 206
Participants Received Treatment 191 204
Cycle 6 141 153
Completed 122 126
Not Completed 81 80
Reason Not Completed
Never received treatment             12             2
Adverse Event             19             25
Lost to Follow-up             7             11
Protocol Violation             12             10
Withdrawal by Subject             4             5
Pregnancy             6             0
Reason not specified or unknown, etc.             21             27
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo Total
Hide Arm/Group Description Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) Total of all reporting groups
Overall Number of Baseline Participants 191 204 395
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 204 participants 395 participants
26.0  (6.6) 26.5  (7.2) 26.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 204 participants 395 participants
Female
191
 100.0%
204
 100.0%
395
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 191 participants 204 participants 395 participants
Caucasian 168 180 348
Black 9 9 18
Hispanic 6 10 16
Asian 4 2 6
Other 4 3 7
1.Primary Outcome
Title The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
Hide Description Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in Full Analysis Set (FAS) with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 158 173
Mean (Standard Deviation)
Unit of Measure: mm
43.05  (23.58) 34.97  (25.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ortho Tri-Cyclen Lo
Comments 2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments Comparison of EV/DNG vs. EE/NGM
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter F-statistic
Estimated Value 9.3218
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
Hide Description Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.
Time Frame From Baseline to Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 148 157
Mean (Standard Deviation)
Unit of Measure: Tablets
Days 1-21 -1.6  (9.9) -3.0  (10.3)
Days 22-28 -5.8  (7.5) -4.6  (8.0)
3.Secondary Outcome
Title The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
Hide Description Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.
Time Frame From Baseline to Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Tablets
Days 1-21 -2.3  (8.3) -3.5  (12.0)
Days 22-28 -5.3  (7.6) -5.2  (8.9)
4.Secondary Outcome
Title Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Time Frame Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 140 153
Mean (Standard Deviation)
Unit of Measure: Days
Headache -1.950  (2.264) -1.425  (2.223)
Pelvic pain -1.921  (2.219) -1.830  (2.093)
Bloating or swelling -1.179  (2.051) -1.131  (1.996)
Breast tenderness -0.536  (1.702) -0.497  (1.755)
Nausea or vomiting -0.207  (1.089) -0.229  (0.892)
5.Secondary Outcome
Title Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Time Frame Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 121 124
Mean (Standard Deviation)
Unit of Measure: Days
Headache -1.909  (2.317) -1.419  (2.053)
Pelvic pain -2.091  (2.074) -2.065  (2.233)
Bloating or swelling -0.959  (1.855) -1.379  (1.868)
Breast tenderness -0.545  (1.727) -0.677  (1.699)
Nausea or vomiting -0.248  (1.113) -0.266  (1.148)
6.Secondary Outcome
Title Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Time Frame Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 143 157
Mean (Standard Deviation)
Unit of Measure: Days
Headache -1.077  (3.407) -0.968  (2.688)
Pelvic pain -0.399  (2.198) -0.624  (2.147)
Bloating or swelling -0.531  (2.325) -0.210  (2.056)
Breast tenderness -0.580  (1.798) -0.248  (1.970)
Nausea or vomiting -0.182  (1.555) -0.172  (1.507)
7.Secondary Outcome
Title Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Time Frame Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 124 129
Mean (Standard Deviation)
Unit of Measure: Days
Headache -1.121  (3.122) -0.767  (2.983)
Pelvic pain -0.274  (2.444) -0.643  (2.113)
Bloating or swelling -0.492  (1.944) -0.279  (2.140)
Breast tenderness -0.274  (1.467) -0.217  (2.042)
Nausea or vomiting -0.298  (1.391) -0.240  (1.457)
8.Secondary Outcome
Title Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.
Time Frame From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 139 153
Mean (Standard Deviation)
Unit of Measure: Days
Headache -0.424  (0.901) -1.425  (2.223)
Pelvic pain -0.273  (1.013) -1.830  (2.093)
Bloating or swelling -0.137  (0.773) -1.131  (1.996)
Breast tenderness -0.043  (0.588) -0.497  (1.755)
Nausea or vomiting -0.043  (0.378) -0.229  (0.892)
9.Secondary Outcome
Title Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Hide Description Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.
Time Frame From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 121 124
Mean (Standard Deviation)
Unit of Measure: Days
Headache -0.537  (0.904) -1.419  (2.053)
Pelvic pain -0.322  (0.977) -2.065  (2.233)
Bloating or swelling -0.107  (0.716) -1.379  (1.868)
Breast tenderness -0.033  (0.515) -0.677  (1.699)
Nausea or vomiting -0.033  (0.407) -0.266  (1.148)
10.Secondary Outcome
Title Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Hide Description Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 154 171
Mean (Standard Deviation)
Unit of Measure: mm
36.92  (24.48) 32.28  (25.77)
11.Secondary Outcome
Title Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Hide Description Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Time Frame Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 122 126
Mean (Standard Deviation)
Unit of Measure: mm
45.89  (23.12) 39.19  (27.68)
12.Secondary Outcome
Title Number of Days With Bleeding or Spotting in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 164 180
Mean (Standard Deviation)
Unit of Measure: Days
19.0  (10.9) 23.7  (8.2)
13.Secondary Outcome
Title Number of Days With Bleeding or Spotting in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 143 156
Mean (Standard Deviation)
Unit of Measure: Days
1.3  (9.2) 18.8  (6.2)
14.Secondary Outcome
Title Number of Days With Bleeding or Spotting in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 138
Mean (Standard Deviation)
Unit of Measure: Days
14.1  (10.4) 19.1  (6.5)
15.Secondary Outcome
Title Number of Days With Bleeding or Spotting in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 125 116
Mean (Standard Deviation)
Unit of Measure: Days
12.8  (9.1) 19.4  (5.3)
16.Secondary Outcome
Title Number of Bleeding / Spotting Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 164 180
Mean (Standard Deviation)
Unit of Measure: Episodes
3.6  (1.4) 3.7  (1.0)
17.Secondary Outcome
Title Number of Bleeding / Spotting Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 143 156
Mean (Standard Deviation)
Unit of Measure: Episodes
3.3  (1.4) 3.4  (0.9)
18.Secondary Outcome
Title Number of Bleeding / Spotting Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 138
Mean (Standard Deviation)
Unit of Measure: Episodes
3.0  (1.4) 3.3  (0.9)
19.Secondary Outcome
Title Number of Bleeding / Spotting Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 125 116
Mean (Standard Deviation)
Unit of Measure: Episodes
3.0  (1.6) 3.7  (0.8)
20.Secondary Outcome
Title Mean Length of Bleeding / Spotting Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 160 180
Mean (Standard Deviation)
Unit of Measure: Days
4.82  (2.50) 6.20  (2.22)
21.Secondary Outcome
Title Mean Length of Bleeding / Spotting Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 136 155
Mean (Standard Deviation)
Unit of Measure: Days
4.46  (2.31) 5.71  (1.99)
22.Secondary Outcome
Title Mean Length of Bleeding / Spotting Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 122 138
Mean (Standard Deviation)
Unit of Measure: Days
4.70  (2.68) 5.85  (1.53)
23.Secondary Outcome
Title Mean Length of Bleeding / Spotting Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 113 116
Mean (Standard Deviation)
Unit of Measure: Days
4.25  (1.57) 5.65  (1.19)
24.Secondary Outcome
Title Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 160 180
Mean (Standard Deviation)
Unit of Measure: Days
7.8  (5.5) 9.0  (4.3)
25.Secondary Outcome
Title Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 136 155
Mean (Standard Deviation)
Unit of Measure: Days
6.2  (3.5) 7.5  (3.7)
26.Secondary Outcome
Title Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 122 138
Mean (Standard Deviation)
Unit of Measure: Days
6.2  (3.5) 7.4  (2.8)
27.Secondary Outcome
Title Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 113 116
Mean (Standard Deviation)
Unit of Measure: Days
5.7  (3.0) 7.1  (2.3)
28.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 160 180
Mean (Standard Deviation)
Unit of Measure: Days
5.1  (5.3) 5.1  (4.2)
29.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 136 155
Mean (Standard Deviation)
Unit of Measure: Days
3.3  (3.2) 3.5  (3.9)
30.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 122 138
Mean (Standard Deviation)
Unit of Measure: Days
3.0  (3.0) 3.1  (3.2)
31.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 113 116
Mean (Standard Deviation)
Unit of Measure: Days
2.7  (3.3) 2.8  (2.9)
32.Secondary Outcome
Title Number of Days With Spotting-only in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 164 180
Mean (Standard Deviation)
Unit of Measure: Days
9.3  (7.5) 8.6  (5.6)
33.Secondary Outcome
Title Number of Days With Spotting-only in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 143 156
Mean (Standard Deviation)
Unit of Measure: Days
6.8  (6.2) 6.4  (4.8)
34.Secondary Outcome
Title Number of Days With Spotting-only in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 138
Mean (Standard Deviation)
Unit of Measure: Days
6.6  (7.1) 6.3  (4.8)
35.Secondary Outcome
Title Number of Days With Spotting-only in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 125 116
Mean (Standard Deviation)
Unit of Measure: Days
5.6  (6.1) 5.6  (3.2)
36.Secondary Outcome
Title Number of Spotting-only Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 164 180
Mean (Standard Deviation)
Unit of Measure: Episodes
1.2  (1.3) 0.5  (0.8)
37.Secondary Outcome
Title Number of Spotting-only Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 143 156
Mean (Standard Deviation)
Unit of Measure: Episodes
1.0  (1.2) 0.5  (0.9)
38.Secondary Outcome
Title Number of Spotting-only Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 138
Mean (Standard Deviation)
Unit of Measure: Episodes
0.7  (1.1) 0.3  (0.6)
39.Secondary Outcome
Title Number of Spotting-only Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 125 116
Mean (Standard Deviation)
Unit of Measure: Episodes
0.6  (1.1) 0.2  (0.5)
40.Secondary Outcome
Title Mean Length of Spotting-only Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 97 59
Mean (Standard Deviation)
Unit of Measure: Days
2.64  (1.67) 2.53  (1.79)
41.Secondary Outcome
Title Mean Length of Spotting-only Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 73 48
Mean (Standard Deviation)
Unit of Measure: Days
2.74  (1.57) 2.77  (2.24)
42.Secondary Outcome
Title Mean Length of Spotting-only Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 51 26
Mean (Standard Deviation)
Unit of Measure: Days
2.75  (1.49) 2.44  (1.54)
43.Secondary Outcome
Title Mean Length of Spotting-only Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 49 21
Mean (Standard Deviation)
Unit of Measure: Days
2.77  (1.77) 2.10  (1.27)
44.Secondary Outcome
Title Maximum Length of Spotting-only Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 97 59
Mean (Standard Deviation)
Unit of Measure: Days
3.3  (2.4) 2.8  (1.9)
45.Secondary Outcome
Title Maximum Length of Spotting-only Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 73 48
Mean (Standard Deviation)
Unit of Measure: Days
3.2  (1.9) 3.1  (2.4)
46.Secondary Outcome
Title Maximum Length of Spotting-only Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 51 26
Mean (Standard Deviation)
Unit of Measure: Days
3.5  (2.2) 2.8  (1.9)
47.Secondary Outcome
Title Maximum Length of Spotting-only Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 49 21
Mean (Standard Deviation)
Unit of Measure: Days
3.2  (2.3) 2.2  (1.3)
48.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
Hide Description Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Time Frame From Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 97 59
Mean (Standard Deviation)
Unit of Measure: Days
1.2  (2.1) 0.5  (1.1)
49.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
Hide Description Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame From Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 73 48
Mean (Standard Deviation)
Unit of Measure: Days
1.0  (1.5) 0.7  (1.3)
50.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
Hide Description Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Time Frame From Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 51 26
Mean (Standard Deviation)
Unit of Measure: Days
1.4  (2.1) 0.6  (1.6)
51.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
Hide Description Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Time Frame From Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 49 21
Mean (Standard Deviation)
Unit of Measure: Days
0.9  (1.9) 0.2  (0.5)
52.Secondary Outcome
Title Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 180 188
Measure Type: Number
Unit of Measure: Percentage of participants
without withdrawal bleeding 25.0 12.8
with withdrawal bleeding 75.0 87.2
53.Secondary Outcome
Title Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 167 182
Measure Type: Number
Unit of Measure: Percentage of participants
without withdrawal bleeding 21.0 7.7
with withdrawal bleeding 79.0 92.3
54.Secondary Outcome
Title Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 157
Measure Type: Number
Unit of Measure: Percentage of participants
without withdrawal bleeding 17.7 8.3
with withdrawal bleeding 82.3 91.7
55.Secondary Outcome
Title Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 110 110
Measure Type: Number
Unit of Measure: Percentage of participants
without withdrawal bleeding 58.2 19.1
with withdrawal bleeding 41.8 80.9
56.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 1
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 135 164
Mean (Standard Deviation)
Unit of Measure: Days
4.2  (2.3) 6.0  (2.6)
57.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 3
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 168
Mean (Standard Deviation)
Unit of Measure: Days
4.3  (2.1) 5.8  (2.0)
58.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 6
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 121 144
Mean (Standard Deviation)
Unit of Measure: Days
4.6  (3.2) 5.7  (1.9)
59.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 13
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 46 89
Mean (Standard Deviation)
Unit of Measure: Days
4.8  (1.8) 5.5  (1.5)
60.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Hide Description Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 135 164
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.2  (0.9) 4.0  (0.8)
61.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Hide Description Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 168
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.2  (0.9) 4.2  (0.7)
62.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Hide Description Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 121 144
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.4  (0.8) 4.0  (0.8)
63.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
Hide Description Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 46 89
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.5  (0.7) 4.1  (0.7)
64.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 1
Hide Description Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 135 164
Mean (Standard Deviation)
Unit of Measure: Days
4.7  (7.0) 4.0  (6.7)
65.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 3
Hide Description Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 132 168
Mean (Standard Deviation)
Unit of Measure: Days
4.3  (7.0) 3.3  (4.7)
66.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 6
Hide Description Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 121 144
Mean (Standard Deviation)
Unit of Measure: Days
5.3  (7.7) 3.1  (5.1)
67.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 13
Hide Description Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 46 89
Mean (Standard Deviation)
Unit of Measure: Days
1.1  (2.2) 2.1  (1.6)
68.Secondary Outcome
Title Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 180 188
Measure Type: Number
Unit of Measure: Percentage of participants
with absence of intracyclic bleeding 78.3 91.5
without absence of intracyclic bleeding 21.7 8.5
69.Secondary Outcome
Title Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 167 182
Measure Type: Number
Unit of Measure: Percentage of participants
with absence of intracyclic bleeding 79.6 85.7
without absence of intracyclic bleeding 20.4 14.3
70.Secondary Outcome
Title Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 157
Measure Type: Number
Unit of Measure: Percentage of participants
with absence of intracyclic bleeding 81.6 80.3
without absence of intracyclic bleeding 18.4 19.7
71.Secondary Outcome
Title Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 110 110
Measure Type: Number
Unit of Measure: Percentage of participants
with absence of intracyclic bleeding 82.7 93.6
without absence of intracyclic bleeding 17.3 6.4
72.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 180 188
Mean (Standard Deviation)
Unit of Measure: Episodes
0.3  (0.5) 0.1  (0.3)
73.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 167 182
Mean (Standard Deviation)
Unit of Measure: Episodes
0.2  (0.5) 0.2  (0.5)
74.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 157
Mean (Standard Deviation)
Unit of Measure: Episodes
0.2  (0.4) 0.2  (0.5)
75.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 110 110
Mean (Standard Deviation)
Unit of Measure: Episodes
0.2  (0.4) 0.1  (0.3)
76.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 39 16
Mean (Standard Deviation)
Unit of Measure: Days
6.7  (8.5) 6.2  (6.2)
77.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 34 26
Mean (Standard Deviation)
Unit of Measure: Days
6.6  (6.0) 4.2  (3.9)
78.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 27 31
Mean (Standard Deviation)
Unit of Measure: Days
5.0  (4.9) 5.2  (5.0)
79.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 19 7
Mean (Standard Deviation)
Unit of Measure: Days
3.0  (2.2) 6.0  (5.9)
80.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 1
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 180 188
Mean (Standard Deviation)
Unit of Measure: Days
1.5  (4.8) 0.5  (2.5)
81.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 3
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 167 182
Mean (Standard Deviation)
Unit of Measure: Days
1.4  (3.8) 0.7  (2.2)
82.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 157
Mean (Standard Deviation)
Unit of Measure: Days
0.9  (2.9) 1.1  (3.1)
83.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 110 110
Mean (Standard Deviation)
Unit of Measure: Days
0.5  (1.5) 0.4  (2.1)
84.Secondary Outcome
Title Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 1 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 39 16
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 46.2 50.0
Light 23.1 18.8
Normal 15.4 18.8
Heavy 15.4 12.5
85.Secondary Outcome
Title Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 3 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 34 26
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 47.1 57.7
Light 23.5 15.4
Normal 20.6 23.1
Heavy 8.8 3.8
86.Secondary Outcome
Title Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 27 31
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 44.4 61.3
Light 25.9 3.2
Normal 18.5 19.4
Heavy 11.1 16.1
87.Secondary Outcome
Title Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Time Frame At Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 31.6 57.1
Light 52.6 0.0
Normal 10.5 28.6
Heavy 5.3 14.3
88.Secondary Outcome
Title Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame Cycles 2 to 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 184 195
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 53.8 40.5
No 46.2 59.5
89.Secondary Outcome
Title Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
Hide Description Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame Cycles 2 to 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 184 195
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 62.0 49.7
No 38.0 50.3
90.Secondary Outcome
Title Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Hide Description Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 155
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Global score 0.41  (6.16) 1.10  (6.96)
Anxiety 0.3  (13.9) 2.8  (16.8)
Depressed mood 0.18  (11.10) -1.04  (13.73)
Positive well-being 49.66  (5.99) 50.29  (6.60)
Self-control 0.69  (9.04) 0.12  (9.17)
General health 81.81  (13.94) 81.12  (13.38)
Vitality -0.17  (8.98) 0.19  (9.55)
91.Secondary Outcome
Title Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Hide Description Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 124 128
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Global score -0.14  (7.41) -0.18  (9.08)
Anxiety -1.2  (16.6) -0.8  (20.4)
Depressed mood -0.65  (13.18) -0.98  (15.96)
Positive well-being 0.60  (8.13) 0.38  (8.43)
Self-control -0.49  (9.47) -0.16  (9.19)
General health 0.86  (14.46) 1.35  (16.15)
Vitality 0.28  (10.99) -0.51  (11.22)
92.Secondary Outcome
Title Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health
Hide Description Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 155
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.13  (14.09) 3.44  (14.32)
93.Secondary Outcome
Title Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health
Hide Description Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 124 128
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.93  (14.37) 2.13  (15.21)
94.Secondary Outcome
Title Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling
Hide Description Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 6 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 147 155
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.12  (9.76) 2.19  (10.96)
95.Secondary Outcome
Title Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling
Hide Description Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 13 (28 days per Cycle)
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Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 124 128
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.44  (12.36) 0.39  (14.35)
96.Secondary Outcome
Title Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work
Hide Description Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 6 (28 days per Cycle)
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Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Overall Number of Participants Analyzed 118 135
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.54  (9.03) 0.08  (10.87)
97.Secondary Outcome
Title Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work
Hide Description Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Time Frame Baseline up to Cycle 13 (28 days per Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in FAS with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ortho Tri-Cyclen Lo
Hide Arm/Group Description:
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cy