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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00293059
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : June 6, 2011
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metrorrhagia
Interventions Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Placebo
Enrollment 190
Recruitment Details The date of first participant, first visit was 14 Dec 2005. The date of last participant, last visit was 21 May 2008.
Pre-assignment Details A total of 1077 participants were screened for inclusion into the study; 887 participants failed screening. The remaining 190 participants were randomized; 120 participants were randomized to the estradiol valerate/dienogest group and 70 participants to the placebo group.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo Matching placebo to be taken orally daily
Period Title: Overall Study
Started 120 70
Subjects Received Treatment 119 66
Cycle 1/Treatment Day 28 115 64
Cycle 3/Treatment Day 84 100 55
Cycle 7/Treatment Day 196 113 [1] 62 [1]
Completed 85 51
Not Completed 35 19
Reason Not Completed
Adverse Event             12             4
Lack of Efficacy             2             0
Lost to Follow-up             2             3
Pregnancy             1             1
Protocol Violation             2             0
Withdrawal by Subject             11             5
Participant moved out of state             1             0
Participant stopped study drug             1             0
Noncompliant - sanitary pads collection             0             1
missing             3             5
[1]
Includes participants that prematurely discontinued and may not be counted in earlier visits.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo Total
Hide Arm/Group Description A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo Matching placebo to be taken orally daily Total of all reporting groups
Overall Number of Baseline Participants 120 70 190
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 70 participants 190 participants
36.9  (7.5) 37.0  (6.7) 36.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
Female
120
 100.0%
70
 100.0%
190
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 120 participants 70 participants 190 participants
26.3  (3.6) 25.8  (3.6) 26.1  (3.6)
excessive bleeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
91 60 151
[1]
Measure Description: 2 or more bleeding episodes in the 90-day run-in phase, each with blood loss ≥80 mL
prolonged bleeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
26 12 38
[1]
Measure Description: 2 or more bleeding episodes in the 90-day run-in phase, each lasting 8 or more days
frequent bleeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
4 2 6
[1]
Measure Description: > 5 bleeding episodes in the 90-day run-in phase, with a minimum of 20 bleeding days overall
prolonged and frequent bleeding  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
3 2 5
prolonged and excessive bleeding  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
9 9 18
frequent and excessive bleeding  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
1 0 1
prolonged, frequent and excessive bleeding  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 70 participants 190 participants
0 0 0
1.Primary Outcome
Title Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Hide Description Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.
Time Frame during a time period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) group consisted of all randomized participants.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 120 70
Measure Type: Number
Unit of Measure: Proportion of participants
0.292 0.029
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method inverting 2 one-sided tests
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants Cured From Prolonged Bleeding
Hide Description Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.
Time Frame during a time period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 26 12
Measure Type: Number
Unit of Measure: Proportion of participants
0.154 0.083
3.Secondary Outcome
Title Proportion of Participants Cured From Frequent Bleeding
Hide Description Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.
Time Frame during a time period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who enrolled with frequent bleeding.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 4 2
Measure Type: Number
Unit of Measure: Proportion of participants
0.250 0.0
4.Secondary Outcome
Title Proportion of Participants Cured From Excessive Bleeding
Hide Description Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.
Time Frame during a time period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who enrolled with excessive bleeding.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 91 60
Measure Type: Number
Unit of Measure: Proportion of participants
0.385 0.05
5.Secondary Outcome
Title Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
Hide Description The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Time Frame from baseline up to treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 100 55
Measure Type: Number
Unit of Measure: Proportion of participants
0.880 0.509
6.Secondary Outcome
Title Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
Hide Description The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.
Time Frame from baseline up to treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 114 62
Measure Type: Number
Unit of Measure: Proportion of participants
0.807 0.419
7.Secondary Outcome
Title Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
Hide Description Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Time Frame from baseline up to treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.835 0.426
8.Secondary Outcome
Title Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
Hide Description Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.
Time Frame from baseline up to treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.812 0.383
9.Secondary Outcome
Title Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
Hide Description Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.
Time Frame Baseline and reference period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 79 46
Mean (Standard Deviation)
Unit of Measure: mL
-353.1  (309.4) -130.4  (338.3)
10.Secondary Outcome
Title Menstrual Blood Loss Volume for All Participants at Cycle 1
Hide Description Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 117 66
Mean (Standard Deviation)
Unit of Measure: mL
136.5  (141.3) 146.9  (133.9)
11.Secondary Outcome
Title Menstrual Blood Loss Volume for All Participants at Cycle 3
Hide Description Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 104 58
Mean (Standard Deviation)
Unit of Measure: mL
59.9  (91.5) 139.6  (92.2)
12.Secondary Outcome
Title Menstrual Blood Loss Volume for All Participants at Cycle 7
Hide Description Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 86 49
Mean (Standard Deviation)
Unit of Measure: mL
41.3  (54.2) 113.3  (76.6)
13.Secondary Outcome
Title Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
Hide Description The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.
Time Frame baseline and reference period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, participants with excessive bleeding at baseline
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 65 42
Mean (Standard Deviation)
Unit of Measure: mL
-411.9  (308.5) -152.3  (343.2)
14.Secondary Outcome
Title Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1
Hide Description The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, participants with excessive bleeding at baseline
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 90 58
Mean (Standard Deviation)
Unit of Measure: mL
206.1  (179.8) 194.7  (132.2)
15.Secondary Outcome
Title Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
Hide Description The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, participants with excessive bleeding at baseline
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 78 51
Mean (Standard Deviation)
Unit of Measure: mL
67.1  (96.2) 147.4  (93.4)
16.Secondary Outcome
Title Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
Hide Description The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, participants with excessive bleeding at baseline
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 68 42
Mean (Standard Deviation)
Unit of Measure: mL
47.5  (58.5) 116.9  (77.5)
17.Secondary Outcome
Title Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
Hide Description The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.
Time Frame baseline and reference period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 79 46
Mean (Standard Deviation)
Unit of Measure: bleeding days
-5.2  (11.4) -2.0  (6.2)
18.Secondary Outcome
Title Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
Hide Description A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.
Time Frame baseline and reference period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 79 46
Mean (Standard Deviation)
Unit of Measure: bleeding episodes
-0.5  (1.5) -0.3  (0.9)
19.Secondary Outcome
Title Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
Hide Description The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.
Time Frame baseline and reference period of 90 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 79 46
Mean (Standard Deviation)
Unit of Measure: Sanitary protection products
-43.6  (40.9) -21.2  (43.2)
20.Secondary Outcome
Title Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84
Hide Description The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 82 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.0  (13.4) -0.7  (10.1)
21.Secondary Outcome
Title Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196
Hide Description The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 81 43
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.7  (14.6) 1.0  (10.1)
22.Secondary Outcome
Title Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84
Hide Description The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 42 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.5  (12.0) 0.8  (8.4)
23.Secondary Outcome
Title Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
Hide Description The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 37 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.0  (15.9) -0.8  (9.1)
24.Secondary Outcome
Title Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
Hide Description The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 86 47
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.0035  (0.2145) -0.0024  (0.1507)
25.Secondary Outcome
Title Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
Hide Description The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.0052  (0.1504) 0.0154  (0.1611)
26.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84
Hide Description The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.07  (11.74) -0.26  (10.38)
27.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196
Hide Description The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 84 47
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.07  (12.86) -0.51  (12.90)
28.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84
Hide Description Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 86 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.221 0.106
29.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
Hide Description Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 75 41
Mean (Standard Deviation)
Unit of Measure: day
0.4  (1.84) 0.7  (1.87)
30.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84
Hide Description Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 78 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.38  (2.175) 3.07  (2.088)
31.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Hide Description Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 80 45
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.81  (2.551) 3.91  (2.466)
32.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
Hide Description Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 86 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.012 0.0
33.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
Hide Description Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.012 0.0
34.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Hide Description Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 86 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.012 0.0
35.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Hide Description Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 103 57
Measure Type: Number
Unit of Measure: Proportion of participants
0.0 0.0
36.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
Hide Description Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 99 54
Measure Type: Number
Unit of Measure: Proportion of participants
0.323 0.407
37.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
Hide Description Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.
Time Frame treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 48
Measure Type: Number
Unit of Measure: Proportion of participants
0.047 0.062
38.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196
Hide Description Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.129 0.213
39.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
Hide Description Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 79 42
Mean (Standard Deviation)
Unit of Measure: days
0.2  (1.19) 0.4  (1.51)
40.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196
Hide Description Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 78 38
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.40  (2.293) 4.03  (3.123)
41.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196
Hide Description Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 80 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.48  (2.291) 4.10  (2.903)
42.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196
Hide Description Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 46
Measure Type: Number
Unit of Measure: Proportion of participants
0.012 0.0
43.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196
Hide Description Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 84 45
Measure Type: Number
Unit of Measure: Proportion of participants
0.024 0.0
44.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
Hide Description Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 84 46
Measure Type: Number
Unit of Measure: Proportion of participants
0.024 0.0
45.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
Hide Description Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 81 45
Measure Type: Number
Unit of Measure: Proportion of participants
0.012 0.0
46.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196
Hide Description Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 87 51
Measure Type: Number
Unit of Measure: Proportion of participants
0.241 0.314
47.Secondary Outcome
Title Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196
Hide Description Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.
Time Frame treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 85 47
Measure Type: Number
Unit of Measure: Proportion of participants
0.047 0.043
48.Secondary Outcome
Title Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196
Hide Description Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 108 59
Mean (Standard Deviation)
Unit of Measure: Percentage of blood volume
1.30  (2.98) 0.09  (3.04)
49.Secondary Outcome
Title Change From Baseline in Serum Ferritin Concentration at Treatment Day 84
Hide Description Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 99 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.2  (35.6) -1.5  (12.2)
50.Secondary Outcome
Title Change From Baseline in Serum Ferritin Concentration at Treatment Day 196
Hide Description Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 112 59
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.3  (37.8) 2.0  (11.9)
51.Secondary Outcome
Title Change From Baseline in Hemoglobin Concentration at Treatment Day 84
Hide Description Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.
Time Frame baseline and treatment day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 96 53
Mean (Standard Deviation)
Unit of Measure: g/dL
0.22  (0.83) 0.17  (0.62)
52.Secondary Outcome
Title Change From Baseline in Hemoglobin Concentration at Treatment Day 196
Hide Description Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.
Time Frame baseline and treatment day 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding participants with missing data
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 108 59
Mean (Standard Deviation)
Unit of Measure: g/dL
0.57  (1.02) 0.20  (1.03)
53.Post-Hoc Outcome
Title Proportion of Participants With Successful Treatment
Hide Description End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.
Time Frame during a time period of 28 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with heavy menstrual bleeding were included in the analysis.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 88 60
Measure Type: Number
Unit of Measure: Proportion of participants
End of study MBL <=80 mL 0.568 0.183
Decrease MBL >=50% of baseline MBL 0.568 0.217
Successful treatment 0.511 0.133
54.Post-Hoc Outcome
Title Change in Absolute Value From Baseline MBL to end-of Study MBL
Hide Description The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).
Time Frame during a time period of 28 days under treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with heavy menstrual bleeding were included in the analysis.
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description:
A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Matching placebo to be taken orally daily
Overall Number of Participants Analyzed 88 60
Mean (Standard Deviation)
Unit of Measure: mL
-114.60  (138.712) -49.944  (117.038)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Hide Arm/Group Description A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo Matching placebo to be taken orally daily
All-Cause Mortality
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/119 (0.84%)      2/66 (3.03%)    
Cardiac disorders     
Myocardial infarction * 1  1/119 (0.84%)  1 0/66 (0.00%)  0
General disorders     
Chest pain * 1  0/119 (0.00%)  0 1/66 (1.52%)  1
Psychiatric disorders     
Suicide attempt * 1  0/119 (0.00%)  0 1/66 (1.52%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/119 (38.66%)      21/66 (31.82%)    
Blood and lymphatic system disorders     
Anaemia * 1  2/119 (1.68%)  3 5/66 (7.58%)  5
Gastrointestinal disorders     
Nausea * 1  7/119 (5.88%)  9 5/66 (7.58%)  7
Infections and infestations     
Nasopharyngitis * 1  9/119 (7.56%)  9 6/66 (9.09%)  7
Vaginitis bacterial * 1  7/119 (5.88%)  8 4/66 (6.06%)  4
Investigations     
Weight increased * 1  10/119 (8.40%)  10 1/66 (1.52%)  1
Nervous system disorders     
Headache * 1  7/119 (5.88%)  8 9/66 (13.64%)  28
Reproductive system and breast disorders     
Breast pain * 1  6/119 (5.04%)  8 0/66 (0.00%)  0
Metrorrhagia * 1  6/119 (5.04%)  7 0/66 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne * 1  6/119 (5.04%)  6 0/66 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00293059    
Other Study ID Numbers: 91469
308960 ( Other Identifier: Company internal )
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: February 23, 2011
Results First Posted: June 6, 2011
Last Update Posted: November 27, 2013