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Effect on Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT00909857
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 27, 2012
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Primary Dysmenorrhea
Interventions Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Ethinyl estradiol, Levonorgestrel (Miranova)
Drug: Placebo Match to SH T00658ID
Drug: Placebo Match to SH D593B
Enrollment 507
Recruitment Details Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.
Pre-assignment Details Out of 771 participants screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 participants were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel).
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Period Title: Overall Study
Started 253 254
Treated 234 230
Completed 217 209
Not Completed 36 45
Reason Not Completed
Withdrawal by Subject             6             10
Adverse Event             5             5
Lost to Follow-up             2             5
Protocol Violation             2             1
Pregnancy             1             0
Other             1             0
Did not receive study medication             19             24
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova) Total
Hide Arm/Group Description Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles Total of all reporting groups
Overall Number of Baseline Participants 234 230 464
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 230 participants 464 participants
28.0  (7.9) 27.6  (8.0) 27.8  (7.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants 230 participants 464 participants
less than 18 years of age 11 13 24
18 years of age or older 223 217 440
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 230 participants 464 participants
Female
234
 100.0%
230
 100.0%
464
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
Hide Description Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Days
-4.6  (4.6) -4.2  (4.2)
2.Secondary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
Hide Description Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. 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: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-10.6  (9.7) -10.0  (8.9)
3.Secondary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
Hide Description Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Days
-4.0  (5.7) -3.7  (5.7)
4.Secondary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
Hide Description Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Days
0.3  (2.6) 0.1  (2.0)
5.Secondary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
Hide Description Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Tablets
-6.2  (14.8) -6.6  (12.3)
6.Secondary Outcome
Title Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
Hide Description Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 219
Mean (Standard Deviation)
Unit of Measure: Tablets
-4.5  (19.9) -5.6  (14.3)
7.Secondary Outcome
Title Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
Hide Description Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 230
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline period-daily activities impaired 92.3 91.3
Baseline period- leisure activities impaired 90.6 89.6
Treatment period-daily activities impaired 51.7 56.5
Treatment period- leisure activities impaired 47.9 56.5
8.Secondary Outcome
Title Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
Hide Description Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time Frame baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 230
Measure Type: Number
Unit of Measure: Percentage of Participants
Baseline period-daily activities impaired 93.2 92.2
Baseline period- leisure activities impaired 92.3 90.0
Treatment period-daily activities impaired 54.7 60.0
Treatment period- leisure activities impaired 52.6 61.3
9.Secondary Outcome
Title Percentage of Participants Satisfied With Study Treatment
Hide Description Participants were asked to express the degree of their satisfaction with study treatment.
Time Frame From cycle 1 to cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 225 216
Measure Type: Number
Unit of Measure: Percentage of participants
Missing 0.9 1.3
Very satisfied 53.4 50.4
Saatisfied 32.1 30.0
Neither satisfied nor dissatisfied 7.3 8.3
Dissatisfied 2.1 3.5
Very dissatisfied 0.4 0.4
10.Secondary Outcome
Title Number of Days With Bleeding or Spotting
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Days
20.0  (8.8) 23.6  (9.7)
11.Secondary Outcome
Title Number of Episodes With Bleeding or Spotting
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Episodes
3.9  (1.0) 4.1  (0.8)
12.Secondary Outcome
Title Mean Length of Bleeding or Spotting Episodes
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Days
5.17  (2.26) 5.83  (2.35)
13.Secondary Outcome
Title Maximum Length of Bleeding or Spotting Episodes
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Days
7.1  (3.8) 8.4  (5.6)
14.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Days
3.6  (3.6) 4.6  (5.6)
15.Secondary Outcome
Title Number of Days With Spotting-only
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Days
7.3  (6.9) 7.6  (7.5)
16.Secondary Outcome
Title Number of Episodes With Spotting-only
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 201 197
Mean (Standard Deviation)
Unit of Measure: Episodes
0.5  (0.8) 0.4  (0.7)
17.Secondary Outcome
Title Mean Length of Spotting Only Episodes
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 67 51
Mean (Standard Deviation)
Unit of Measure: Days
3.29  (2.39) 3.26  (2.79)
18.Secondary Outcome
Title Maximum Length of Spotting Only Episodes
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 67 51
Mean (Standard Deviation)
Unit of Measure: Days
3.9  (3.1) 3.6  (3.0)
19.Secondary Outcome
Title Difference in Duration Between Longest and Shortest Spotting Only Episode
Hide Description Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time Frame From day 1 to day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 67 51
Mean (Standard Deviation)
Unit of Measure: Days
1.2  (2.5) 0.7  (1.5)
20.Secondary Outcome
Title Percentage of Participants With Withdrawal Bleeding at Cycle 1
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 222
Measure Type: Number
Unit of Measure: Percentage of Participants
91.2 93.2
21.Secondary Outcome
Title Percentage of Participants With Withdrawal Bleeding at Cycle 3
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 204 198
Measure Type: Number
Unit of Measure: Percentage of Participants
68.1 79.3
22.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 1
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 206 207
Mean (Standard Deviation)
Unit of Measure: Days
5.2  (2.7) 5.4  (2.4)
23.Secondary Outcome
Title Length of Withdrawal Bleeding Episodes at Cycle 3
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 139 157
Mean (Standard Deviation)
Unit of Measure: Days
4.5  (1.7) 5.2  (2.0)
24.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 206 207
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.7  (1.0) 4.0  (0.9)
25.Secondary Outcome
Title Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 139 157
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.7  (0.8) 4.1  (0.8)
26.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 1
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 206 207
Mean (Standard Deviation)
Unit of Measure: Days
4.8  (7.0) 4.9  (5.9)
27.Secondary Outcome
Title Onset of Withdrawal Bleeding Episodes at Cycle 3
Hide Description Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 139 157
Mean (Standard Deviation)
Unit of Measure: Days
3.1  (3.7) 4.3  (4.4)
28.Secondary Outcome
Title Percentage of Participants With Intracyclic Bleeding at Cycle 1
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 222
Measure Type: Number
Unit of Measure: Percentage of Participants
19.0 16.7
29.Secondary Outcome
Title Percentage of Participants With Intracyclic Bleeding at Cycle 3
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 204 198
Measure Type: Number
Unit of Measure: Percentage of Participants
10.8 11.6
30.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 222
Mean (Standard Deviation)
Unit of Measure: Episodes
0.2  (0.5) 0.2  (0.4)
31.Secondary Outcome
Title Number of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 204 198
Mean (Standard Deviation)
Unit of Measure: Episodes
0.1  (0.3) 0.1  (0.4)
32.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 43 37
Mean (Standard Deviation)
Unit of Measure: Days
6.0  (5.4) 6.2  (5.7)
33.Secondary Outcome
Title Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 22 23
Mean (Standard Deviation)
Unit of Measure: Days
5.5  (4.7) 4.9  (4.1)
34.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 1
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 222
Mean (Standard Deviation)
Unit of Measure: Days
1.2  (3.5) 1.0  (3.3)
35.Secondary Outcome
Title Number of Intracyclic Bleeding Days at Cycle 3
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 204 198
Mean (Standard Deviation)
Unit of Measure: Days
0.6  (2.3) 0.6  (2.1)
36.Secondary Outcome
Title Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Time Frame At cycle 1 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 43 37
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 53.5 62.2
Light 30.2 10.8
Normal 9.3 13.5
Heavy 7.0 13.5
37.Secondary Outcome
Title Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Hide Description Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Time Frame At cycle 3 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Percentage of participants
Spotting 45.5 30.4
Light 27.3 21.7
Normal 13.6 30.4
Heavy 13.6 17.4
38.Secondary Outcome
Title Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
Hide Description The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time Frame At screening (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 230
Measure Type: Number
Unit of Measure: Percentage of Participants
Missing 0.4 0.0
Never 38.0 40.4
4 working hours 16.2 16.1
1 working day 26.5 29.6
>= 2 working days 18.8 13.9
39.Secondary Outcome
Title Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
Hide Description The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time Frame At Baseline (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Measure Type: Number
Unit of Measure: Percentage of Participants
Missing 0.0 0.0
Never 47.9 51.7
4 working hours 13.2 11.7
1 working day 20.9 23.9
>= 2 working days 17.9 12.2
40.Secondary Outcome
Title Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
Hide Description The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time Frame At cycle 2 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 224 212
Measure Type: Number
Unit of Measure: Percentage of Participants
Missing 0.0 0.0
Never 78.6 72.6
4 working hours 8.5 6.5
1 working day 6.4 8.7
>= 2 working days 2.1 4.3
41.Secondary Outcome
Title Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
Hide Description The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Measure Type: Number
Unit of Measure: Percentage of Participants
Missing 0.4 0.0
Never 85.9 85.2
4 working hours 5.6 2.6
1 working day 3.0 4.8
>= 2 working days 1.7 1.7
42.Secondary Outcome
Title Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 173 174
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
43.Secondary Outcome
Title Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 206 195
Median (Full Range)
Unit of Measure: Dollars
5.46
(0.00 to 30.00)
5.04
(0.00 to 27.49)
44.Secondary Outcome
Title Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 173 176
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 65.45)
0.00
(0.00 to 65.45)
45.Secondary Outcome
Title Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 172 172
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 60.00)
0.00
(0.00 to 295.98)
46.Secondary Outcome
Title Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 174 174
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 150.00)
0.00
(0.00 to 74.00)
47.Secondary Outcome
Title Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 170 170
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 271.68)
0.00
(0.00 to 98.17)
48.Secondary Outcome
Title Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 177 175
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 196.34)
0.00
(0.00 to 110.00)
49.Secondary Outcome
Title Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 183 179
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 30.00)
0.00
(0.00 to 10.00)
50.Secondary Outcome
Title Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
Hide Description The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time Frame At screening (average over 3 months before screening)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 192 194
Median (Full Range)
Unit of Measure: Dollars
0.00
(0.00 to 15.00)
0.00
(0.00 to 42.00)
51.Secondary Outcome
Title Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Hide Description The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the participants' improvement during the course of the study.
Time Frame At cycle 2 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 223 210
Measure Type: Number
Unit of Measure: Participants
Missing 0 0
Not assessed 1 1
Very much improved 63 42
Much improved 87 84
Minimally improved 49 54
No change 17 23
Minimally worse 6 3
Much worse 0 6
52.Secondary Outcome
Title Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Hide Description The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Participants were asked to rate their improvement during the course of the study.
Time Frame At cycle 2 (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 223 210
Measure Type: Number
Unit of Measure: Participants
Missing 1 0
Not assessed 1 1
Very much improved 60 46
Much improved 91 75
Minimally improved 47 57
No change 18 24
Minimally worse 5 4
Much worse 0 3
53.Secondary Outcome
Title Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
90.2  (16.7) 89.6  (17.5)
54.Secondary Outcome
Title Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame at final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
93.7  (14.2) 92.5  (15.0)
55.Secondary Outcome
Title Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
78.85  (18.99) 77.35  (20.56)
56.Secondary Outcome
Title Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
85.95  (19.09) 84.79  (17.36)
57.Secondary Outcome
Title Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
73.6  (15.6) 72.6  (16.3)
58.Secondary Outcome
Title Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
77.3  (14.9) 76.4  (14.7)
59.Secondary Outcome
Title Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
62.6  (18.0) 62.2  (18.2)
60.Secondary Outcome
Title Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
68.2  (17.0) 67.2  (16.8)
61.Secondary Outcome
Title General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
75.8  (17.5) 72.7  (16.9)
62.Secondary Outcome
Title General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
77.2  (17.9) 76.5  (16.6)
63.Secondary Outcome
Title Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
77.8  (33.6) 79.4  (32.7)
64.Secondary Outcome
Title Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
89.6  (23.0) 87.9  (25.9)
65.Secondary Outcome
Title Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
81.91  (31.50) 79.18  (34.74)
66.Secondary Outcome
Title Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
88.64  (26.36) 83.87  (30.28)
67.Secondary Outcome
Title Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At baseline cycle (28 days per cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 234 229
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
50.7  (24.4) 51.8  (23.0)
68.Secondary Outcome
Title Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
Hide Description The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time Frame At final examination (28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description:
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Overall Number of Participants Analyzed 226 217
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
77.0  (21.5) 74.0  (22.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Hide Arm/Group Description Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
All-Cause Mortality
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/234 (0.85%)      2/230 (0.87%)    
Infections and infestations     
Helminthic infection * 1  1/234 (0.43%)  1 0/230 (0.00%)  0
Injury, poisoning and procedural complications     
Animal bite * 1  0/234 (0.00%)  0 1/230 (0.43%)  1
Psychiatric disorders     
Depression * 1  0/234 (0.00%)  0 1/230 (0.43%)  1
Reproductive system and breast disorders     
Ovarian torsion * 1  1/234 (0.43%)  1 0/230 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   131/234 (55.98%)      122/230 (53.04%)    
Gastrointestinal disorders     
Dental caries * 1  5/234 (2.14%)  10 2/230 (0.87%)  7
Nausea * 1  2/234 (0.85%)  2 5/230 (2.17%)  6
General disorders     
Inflammation * 1  7/234 (2.99%)  7 3/230 (1.30%)  3
Infections and infestations     
Influenza * 1  2/234 (0.85%)  2 5/230 (2.17%)  5
Upper respiratory tract infection * 1  4/234 (1.71%)  6 7/230 (3.04%)  10
Nervous system disorders     
Headache * 1  32/234 (13.68%)  55 34/230 (14.78%)  55
Tension headache * 1  14/234 (5.98%)  40 9/230 (3.91%)  43
Reproductive system and breast disorders     
Cervical dysplasia * 1  7/234 (2.99%)  7 9/230 (3.91%)  9
Dysfunctional uterine bleeding * 1  3/234 (1.28%)  4 5/230 (2.17%)  6
Dysmenorrhoea * 1  87/234 (37.18%)  208 82/230 (35.65%)  210
Metrorrhagia * 1  18/234 (7.69%)  28 13/230 (5.65%)  17
Cervix inflammation * 1  9/234 (3.85%)  9 4/230 (1.74%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00909857     History of Changes
Other Study ID Numbers: 91781
2008-005625-11 ( EudraCT Number )
312042 ( Other Identifier: Bayer )
First Submitted: April 24, 2009
First Posted: May 29, 2009
Results First Submitted: November 15, 2011
Results First Posted: February 27, 2012
Last Update Posted: August 24, 2015