Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

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: NCT00461305
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : October 1, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by:
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dysmenorrhea
Interventions Drug: DRSP 3 mg/EE 20 µg (13 cycles)
Drug: DRSP 3 mg/EE 30 µg (6 cycles)
Enrollment 420
Recruitment Details  
Pre-assignment Details Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6.
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Period Title: Treatment
Started 355 [1] 65 [1]
Subjects Dispensed Drugs 350 65
Subjects Received Treatment 349 [2] 65 [2]
Completed 254 56
Not Completed 101 9
Reason Not Completed
Adverse Event             26             3
Lost to Follow-up             4             2
Protocol Violation             13             2
Withdrawal by Subject             48             2
Never dispensed             5             0
Study drug not taken             1             0
Partially missing diary             2             0
Other (missing drug etc)             2             0
[1]
Enrolled
[2]
FAS, safety population
Period Title: Continued Treatment
Started 349 [1] 0 [2]
Completed 254 0
Not Completed 95 0
Reason Not Completed
Adverse Event             26             0
Lost to Follow-up             4             0
Protocol Violation             13             0
Withdrawal by Subject             48             0
Partially missing diary             2             0
Other (missing drug etc)             2             0
[1]
FAS, participants from previous treatment who were available to continue treatment
[2]
no participants were treated with the DRSP 3 mg/EE 30 μg combination beyond 6 cycles
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles) Total
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) Total of all reporting groups
Overall Number of Baseline Participants 349 65 414
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 349 participants 65 participants 414 participants
29.0
(20 to 44)
30.9
(20 to 43)
29.3
(20 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 65 participants 414 participants
Female
349
 100.0%
65
 100.0%
414
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Diagnosis type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 349 participants 65 participants 414 participants
Functional dysmenorrhea 273 53 326
Organic dysmenorrhea 76 12 88
Details of organic dysmenorrhea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 349 participants 65 participants 414 participants
Endometriosis 24 4 28
Uterine fibroids 27 7 34
Uterine adenomyosis 35 8 43
Endometrial polyp 1 0 1
Bicornuate uterus 3 0 3
Multiple endometrial polyp 1 0 1
Uterine enlargement 1 0 1
[1]
Measure Description: Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.
Average length of menstrual cycle  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 349 participants 65 participants 414 participants
29.5
(25 to 38)
29.5
(25 to 38)
29.5
(25 to 38)
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 349 participants 65 participants 414 participants
20.73
(16.2 to 29.9)
20.56
(15.3 to 28.7)
20.70
(15.3 to 29.9)
1.Primary Outcome
Title Number of Participants With Intracyclic Bleeding at Cycle 6
Hide Description Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 299 56
Measure Type: Number
Unit of Measure: participants
40 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRSP 3 mg/EE 20 µg (6 Cycles)
Comments Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binominal parameter by exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence on one treatment arm
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
9.73 to 17.77
Estimation Comments No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRSP 3 mg/EE 30 µg (6 Cycles)
Comments Exact 95% confident intervals were calculated using F-distribution by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binominal parameter by exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence on one treatment arm
Estimated Value 7.1
Confidence Interval 95%
1.98 to 17.29
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Time Frame From baseline up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
-6 (change in total dysmenorrhea scores) 5 2
-5 (change in total dysmenorrhea scores) 22 3
-4 (change in total dysmenorrhea scores) 41 8
-3 (change in total dysmenorrhea scores) 70 13
-2 (change in total dysmenorrhea scores) 71 10
-1 (change in total dysmenorrhea scores) 30 12
0 (change in total dysmenorrhea scores) 25 4
1 (change in total dysmenorrhea scores) 4 2
2 (change in total dysmenorrhea scores) 4 0
3 (change in total dysmenorrhea scores) 0 0
4 (change in total dysmenorrhea scores) 0 0
5 (change in total dysmenorrhea scores) 0 0
6 (change in total dysmenorrhea scores) 0 0
3.Secondary Outcome
Title Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Time Frame From baseline up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
-6 (change in total dysmenorrhea scores) 4
-5 (change in total dysmenorrhea scores) 22
-4 (change in total dysmenorrhea scores) 47
-3 (change in total dysmenorrhea scores) 68
-2 (change in total dysmenorrhea scores) 44
-1 (change in total dysmenorrhea scores) 32
0 (change in total dysmenorrhea scores) 12
1 (change in total dysmenorrhea scores) 11
2 (change in total dysmenorrhea scores) 2
3 (change in total dysmenorrhea scores) 0
4 (change in total dysmenorrhea scores) 0
5 (change in total dysmenorrhea scores) 0
6 (change in total dysmenorrhea scores) 0
4.Secondary Outcome
Title Distribution of Total Dysmenorrhea Score at Cycle 6
Hide Description Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
0 65 13
1 79 16
2 49 9
3 42 8
4 19 3
5 17 4
6 1 1
5.Secondary Outcome
Title Distribution of Total Dysmenorrhea Score at Cycle 13
Hide Description Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
0 73
1 66
2 41
3 24
4 24
5 13
6 1
6.Secondary Outcome
Title Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
Hide Description Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
none 75 14
mild 119 19
moderate 59 16
severe 19 5
7.Secondary Outcome
Title Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
Hide Description Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
none 78
mild 106
moderate 47
severe 11
8.Secondary Outcome
Title Distribution of Severity of Lumbago During Menstruation at Cycle 6
Hide Description Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
none 154 21
mild 88 29
moderate 26 2
severe 4 2
9.Secondary Outcome
Title Distribution of Severity of Lumbago During Menstruation at Cycle 13
Hide Description Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
none 148
mild 72
moderate 19
severe 3
10.Secondary Outcome
Title Distribution of Severity of Headache During Menstruation at Cycle 6
Hide Description Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
none 187 37
mild 41 4
moderate 29 11
severe 15 2
11.Secondary Outcome
Title Distribution of Severity of Headache During Menstruation at Cycle 13
Hide Description Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
none 168
mild 38
moderate 30
severe 6
12.Secondary Outcome
Title Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
Hide Description Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Measure Type: Number
Unit of Measure: participants
none 251 51
mild 14 1
moderate 4 2
severe 3 0
13.Secondary Outcome
Title Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
Hide Description Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
none 229
mild 11
moderate 2
severe 0
14.Secondary Outcome
Title Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
Hide Description Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 271 54
Measure Type: Number
Unit of Measure: participants
0 202 34
1 52 13
2 11 4
3 2 1
4 2 1
5 2 0
6 0 1
15.Secondary Outcome
Title Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
Hide Description Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: participants
0 177
1 49
2 12
3 2
4 2
5 0
6 0
16.Secondary Outcome
Title Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame From baseline up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 272 54
Mean (Full Range)
Unit of Measure: scores on a scale
-37.2
(-91 to 47)
-31.9
(-71 to 13)
17.Secondary Outcome
Title Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame From baseline up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Mean (Full Range)
Unit of Measure: scores on a scale
-41.6
(-91 to 36)
18.Secondary Outcome
Title Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame From baseline up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 271 54
Mean (Full Range)
Unit of Measure: scores on a scale
6.7
(0 to 80)
12.2
(0 to 83)
19.Secondary Outcome
Title Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame From baseline up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 242
Mean (Full Range)
Unit of Measure: scores on a scale
6.2
(0 to 65)
20.Secondary Outcome
Title Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Hide Description Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 326 60
Mean (Full Range)
Unit of Measure: number of episodes
Reference period 1
3.3
(1 to 7)
3.4
(1 to 7)
Reference period 2
3.3
(0 to 10)
3.1
(2 to 7)
21.Secondary Outcome
Title Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Hide Description Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 333
Mean (Full Range)
Unit of Measure: number of episodes
Reference period 1
3.2
(1 to 7)
Reference period 2
3.5
(0 to 10)
Reference period 3
3.1
(0 to 8)
Reference period 4
3.2
(0 to 8)
22.Secondary Outcome
Title Number of Any Bleeding Days From Cycle 1 to Cycle 6
Hide Description Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 326 60
Mean (Full Range)
Unit of Measure: days
Reference period 1
30.7
(14 to 65)
28.9
(13 to 65)
Reference period 2
19.3
(0 to 78)
19.9
(9 to 42)
23.Secondary Outcome
Title Number of Any Bleeding Days From Cycle 1 to Cycle 13
Hide Description Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 337
Mean (Full Range)
Unit of Measure: days
Reference period 1
30.6
(14 to 65)
Reference period 2
19.8
(0 to 79)
Reference period 3
21.2
(0 to 88)
Reference period 4
17.7
(0 to 69)
24.Secondary Outcome
Title Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Hide Description Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 341 62
Measure Type: Number
Unit of Measure: participants
Cycle 1 94 19
Cycle 2 38 8
Cycle 3 45 8
Cycle 4 33 3
Cycle 5 40 5
Cycle 6 29 4
25.Secondary Outcome
Title Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Hide Description Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 343
Measure Type: Number
Unit of Measure: participants
Cycle 1 93
Cycle 2 38
Cycle 3 45
Cycle 4 33
Cycle 5 41
Cycle 6 40
Cycle 7 114
Cycle 8 24
Cycle 9 24
Cycle 10 24
Cycle 11 21
Cycle 12 23
Cycle 13 31
26.Secondary Outcome
Title Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Hide Description Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 341 62
Measure Type: Number
Unit of Measure: participants
Cycle 1 276 54
Cycle 2 310 57
Cycle 3 302 58
Cycle 4 290 54
Cycle 5 279 54
Cycle 6 185 52
27.Secondary Outcome
Title Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Hide Description Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 343
Measure Type: Number
Unit of Measure: participants
Cycle 1 274
Cycle 2 314
Cycle 3 307
Cycle 4 295
Cycle 5 289
Cycle 6 285
Cycle 7 229
Cycle 8 259
Cycle 9 245
Cycle 10 250
Cycle 11 246
Cycle 12 243
Cycle 13 241
28.Secondary Outcome
Title Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Hide Description Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 349 65
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 90.3 89.5
Cycle 2 97.4 100.0
Cycle 3 91.1 100.0
Cycle 4 87.9 100.0
Cycle 5 87.8 80.0
Cycle 6 92.5 100.0
29.Secondary Outcome
Title Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Hide Description Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 349
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 90.3
Cycle 2 97.4
Cycle 3 91.1
Cycle 4 87.9
Cycle 5 87.8
Cycle 6 92.5
Cycle 7 90.4
Cycle 8 100.0
Cycle 9 87.5
Cycle 10 100.0
Cycle 11 100.0
Cycle 12 100.0
Cycle 13 90.3
30.Secondary Outcome
Title Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Hide Description Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time Frame Up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 349 65
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 90.1 87.0
Cycle 2 90.8 94.7
Cycle 3 91.2 87.9
Cycle 4 92.2 92.6
Cycle 5 92.7 88.9
Cycle 6 90.9 88.5
31.Secondary Outcome
Title Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Hide Description Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time Frame Up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 349
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 90.1
Cycle 2 90.8
Cycle 3 91.2
Cycle 4 92.2
Cycle 5 92.7
Cycle 6 90.9
Cycle 7 91.3
Cycle 8 91.1
Cycle 9 91.0
Cycle 10 90.8
Cycle 11 91.9
Cycle 12 93.8
Cycle 13 93.8
32.Secondary Outcome
Title Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
Hide Description CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time Frame From baseline up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS(Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 281 56
Mean (Full Range)
Unit of Measure: Units/mL
-4.33
(-134.8 to 46.1)
-5.50
(-102.6 to 3.2)
33.Secondary Outcome
Title Change in Serum CA-125 From Baseline to Cycle 13
Hide Description CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time Frame From baseline up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 254
Mean (Full Range)
Unit of Measure: Units/mL
-4.66
(-135.5 to 90.0)
34.Secondary Outcome
Title Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
Hide Description CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Time Frame From baseline up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS(Participants with data at Cycle 6)
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 281 56
Mean (Full Range)
Unit of Measure: mg/dL
0.159
(-0.83 to 7.98)
0.000
(-1.62 to 1.37)
35.Secondary Outcome
Title Change in Serum CRP From Baseline to Cycle 13
Hide Description CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Time Frame From baseline up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 254
Mean (Full Range)
Unit of Measure: mg/dL
0.014
(-0.90 to 1.99)
36.Post-Hoc Outcome
Title Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
Hide Description Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Baseline and up to Cycle 6 (168 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title DRSP 3 mg/EE 20 µg (6 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Overall Number of Participants Analyzed 349 65
Mean (Standard Deviation)
Unit of Measure: scores on a scale
age: < 30 years -2.4  (1.68) -2.2  (1.64)
age: >= 30 years -2.2  (1.52) -2.1  (1.69)
weight: < 50 kg -2.0  (1.58) -2.3  (1.76)
weight: >= 50kg -2.5  (1.61) -2.0  (1.60)
functional dysmenorrhea -2.4  (1.64) -2.3  (1.54)
organic dysmenorrhea -2.0  (1.45) -1.3  (1.91)
with medical surgical history -2.3  (1.61) -2.0  (1.69)
without medical surgical history -2.4  (1.54) -2.4  (1.60)
with previous medication -2.3  (1.61) -2.1  (1.66)
with pregnancy history -2.2  (1.67) -2.1  (1.68)
with birth history -2.0  (1.71) -2.4  (1.83)
total dysmenorrhea score at baseline 3/4 -1.9  (1.37) -1.9  (1.37)
total dysmenorrhea score at baseline 5/6 -3.0  (1.73) -2.6  (2.04)
37.Post-Hoc Outcome
Title Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
Hide Description Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Baseline and up to Cycle 13 (364 days) with 28 days per cycle
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles)
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Overall Number of Participants Analyzed 349
Mean (Standard Deviation)
Unit of Measure: scores on a scale
age: < 30 years -2.5  (1.67)
age: >= 30 years -2.4  (1.70)
weight: < 50 kg -2.1  (1.68)
weight: >= 50kg -2.7  (1.65)
functional dysmenorrhea -2.6  (1.70)
organic dysmenorrhea -2.1  (1.59)
with medical surgical history -2.5  (1.72)
without medical surgical history -2.5  (1.64)
with previous medication -2.5  (1.69)
with pregnancy history -2.1  (1.75)
with birth history -1.9  (1.76)
total dysmenorrhea score at baseline 3/4 -2.0  (1.48)
total dysmenorrhea score at baseline 5/6 -3.2  (1.75)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
All-Cause Mortality
DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/355 (1.41%)      0/65 (0.00%)    
Infections and infestations     
Appendicitis * 1  1/355 (0.28%)  1 0/65 (0.00%)  0
Enteritis infectious * 1  1/355 (0.28%)  1 0/65 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial cancer * 1  1/355 (0.28%)  1 0/65 (0.00%)  0
Nervous system disorders     
Facial palsy * 1  1/355 (0.28%)  1 0/65 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/355 (0.28%)  1 0/65 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DRSP 3 mg/EE 20 µg (13 Cycles) DRSP 3 mg/EE 30 µg (6 Cycles)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   335/355 (94.37%)      63/65 (96.92%)    
Gastrointestinal disorders     
Abdominal pain lower * 1  53/355 (14.93%)  68 5/65 (7.69%)  6
Abdominal pain upper * 1  13/355 (3.66%)  17 5/65 (7.69%)  5
Constipation * 1  19/355 (5.35%)  20 1/65 (1.54%)  1
Diarrhoea * 1  24/355 (6.76%)  35 3/65 (4.62%)  3
Nausea * 1  128/355 (36.06%)  217 25/65 (38.46%)  37
Vomiting * 1  22/355 (6.20%)  24 4/65 (6.15%)  4
Immune system disorders     
Seasonal allergy * 1  35/355 (9.86%)  38 4/65 (6.15%)  4
Infections and infestations     
Nasopharyngitis * 1  182/355 (51.27%)  339 34/65 (52.31%)  44
Vulvovaginal candidiasis * 1  19/355 (5.35%)  20 0/65 (0.00%)  0
Injury, poisoning and procedural complications     
Post procedural haemorrhage * 1  55/355 (15.49%)  82 11/65 (16.92%)  11
Procedural pain * 1  19/355 (5.35%)  25 1/65 (1.54%)  1
Investigations     
Blood triglycerides increased * 1  29/355 (8.17%)  33 2/65 (3.08%)  3
Plasminogen increased * 1  18/355 (5.07%)  18 7/65 (10.77%)  7
Protein S decreased * 1  9/355 (2.54%)  9 6/65 (9.23%)  6
Thrombin-antithrombin III complex increased * 1  35/355 (9.86%)  39 1/65 (1.54%)  1
Blood alkaline phosphatase decreased * 1  3/355 (0.85%)  3 4/65 (6.15%)  4
Coagulation test abnormal * 1  70/355 (19.72%)  71 12/65 (18.46%)  12
Musculoskeletal and connective tissue disorders     
Back pain * 1  25/355 (7.04%)  34 2/65 (3.08%)  2
Nervous system disorders     
Headache * 1  215/355 (60.56%)  679 39/65 (60.00%)  81
Reproductive system and breast disorders     
Dysmenorrhoea * 1  124/355 (34.93%)  268 20/65 (30.77%)  42
Menorrhagia * 1  16/355 (4.51%)  21 4/65 (6.15%)  7
Metrorrhagia * 1  97/355 (27.32%)  235 9/65 (13.85%)  23
Breast discomfort * 1  13/355 (3.66%)  15 5/65 (7.69%)  5
Genital haemorrhage * 1  97/355 (27.32%)  194 14/65 (21.54%)  26
Respiratory, thoracic and mediastinal disorders     
Rhinitis allergic * 1  22/355 (6.20%)  24 3/65 (4.62%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
Sponsor will confirm the contents before disclosure.
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: Therapeutic Area Head, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00461305     History of Changes
Other Study ID Numbers: 91616
310284 ( Other Identifier: Company Internal )
First Submitted: April 17, 2007
First Posted: April 18, 2007
Results First Submitted: September 10, 2010
Results First Posted: October 1, 2010
Last Update Posted: January 24, 2013