Trial Outcomes & Findings for Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea (NCT NCT00461305)
NCT ID: NCT00461305
Last Updated: 2013-01-24
Results Overview
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
420 participants
Primary outcome timeframe
Up to Cycle 6 (168 days) with 28 days per cycle
Results posted on
2013-01-24
Participant Flow
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.
Participant milestones
| Measure |
DRSP 3 mg/EE 20 µg (13 Cycles)
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Treatment
STARTED
|
355
|
65
|
|
Treatment
Subjects Dispensed Drugs
|
350
|
65
|
|
Treatment
Subjects Received Treatment
|
349
|
65
|
|
Treatment
COMPLETED
|
254
|
56
|
|
Treatment
NOT COMPLETED
|
101
|
9
|
|
Continued Treatment
STARTED
|
349
|
0
|
|
Continued Treatment
COMPLETED
|
254
|
0
|
|
Continued Treatment
NOT COMPLETED
|
95
|
0
|
Reasons for withdrawal
| Measure |
DRSP 3 mg/EE 20 µg (13 Cycles)
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Treatment
Adverse Event
|
26
|
3
|
|
Treatment
Lost to Follow-up
|
4
|
2
|
|
Treatment
Protocol Violation
|
13
|
2
|
|
Treatment
Withdrawal by Subject
|
48
|
2
|
|
Treatment
Never dispensed
|
5
|
0
|
|
Treatment
Study drug not taken
|
1
|
0
|
|
Treatment
Partially missing diary
|
2
|
0
|
|
Treatment
Other (missing drug etc)
|
2
|
0
|
|
Continued Treatment
Adverse Event
|
26
|
0
|
|
Continued Treatment
Lost to Follow-up
|
4
|
0
|
|
Continued Treatment
Protocol Violation
|
13
|
0
|
|
Continued Treatment
Withdrawal by Subject
|
48
|
0
|
|
Continued Treatment
Partially missing diary
|
2
|
0
|
|
Continued Treatment
Other (missing drug etc)
|
2
|
0
|
Baseline Characteristics
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Baseline characteristics by cohort
| Measure |
DRSP 3 mg/EE 20 µg (13 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 Participants
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
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
29.0 years
n=5 Participants
|
30.9 years
n=7 Participants
|
29.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Diagnosis type
Functional dysmenorrhea
|
273 participants
n=5 Participants
|
53 participants
n=7 Participants
|
326 participants
n=5 Participants
|
|
Diagnosis type
Organic dysmenorrhea
|
76 participants
n=5 Participants
|
12 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Endometriosis
|
24 participants
n=5 Participants
|
4 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Uterine fibroids
|
27 participants
n=5 Participants
|
7 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Uterine adenomyosis
|
35 participants
n=5 Participants
|
8 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Endometrial polyp
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Bicornuate uterus
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Multiple endometrial polyp
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Details of organic dysmenorrhea
Uterine enlargement
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Average length of menstrual cycle
|
29.5 days
n=5 Participants
|
29.5 days
n=7 Participants
|
29.5 days
n=5 Participants
|
|
Body Mass Index
|
20.73 kg/m^2
n=5 Participants
|
20.56 kg/m^2
n=7 Participants
|
20.70 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=299 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=56 Participants
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)
|
|---|---|---|
|
Number of Participants With Intracyclic Bleeding at Cycle 6
|
40 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-6 (change in total dysmenorrhea scores)
|
5 participants
|
2 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-3 (change in total dysmenorrhea scores)
|
70 participants
|
13 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
0 (change in total dysmenorrhea scores)
|
25 participants
|
4 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
2 (change in total dysmenorrhea scores)
|
4 participants
|
0 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
4 (change in total dysmenorrhea scores)
|
0 participants
|
0 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
5 (change in total dysmenorrhea scores)
|
0 participants
|
0 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
6 (change in total dysmenorrhea scores)
|
0 participants
|
0 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-5 (change in total dysmenorrhea scores)
|
22 participants
|
3 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-4 (change in total dysmenorrhea scores)
|
41 participants
|
8 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-2 (change in total dysmenorrhea scores)
|
71 participants
|
10 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
-1 (change in total dysmenorrhea scores)
|
30 participants
|
12 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
1 (change in total dysmenorrhea scores)
|
4 participants
|
2 participants
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
3 (change in total dysmenorrhea scores)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-2 (change in total dysmenorrhea scores)
|
44 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-1 (change in total dysmenorrhea scores)
|
32 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
0 (change in total dysmenorrhea scores)
|
12 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
1 (change in total dysmenorrhea scores)
|
11 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
2 (change in total dysmenorrhea scores)
|
2 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
3 (change in total dysmenorrhea scores)
|
0 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
6 (change in total dysmenorrhea scores)
|
0 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-6 (change in total dysmenorrhea scores)
|
4 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-5 (change in total dysmenorrhea scores)
|
22 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-4 (change in total dysmenorrhea scores)
|
47 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
-3 (change in total dysmenorrhea scores)
|
68 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
4 (change in total dysmenorrhea scores)
|
0 participants
|
—
|
|
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
5 (change in total dysmenorrhea scores)
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
6
|
1 participants
|
1 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
0
|
65 participants
|
13 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
1
|
79 participants
|
16 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
2
|
49 participants
|
9 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
3
|
42 participants
|
8 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
4
|
19 participants
|
3 participants
|
|
Distribution of Total Dysmenorrhea Score at Cycle 6
5
|
17 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
0
|
73 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
1
|
66 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
2
|
41 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
3
|
24 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
4
|
24 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
5
|
13 participants
|
—
|
|
Distribution of Total Dysmenorrhea Score at Cycle 13
6
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
none
|
75 participants
|
14 participants
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
mild
|
119 participants
|
19 participants
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
severe
|
19 participants
|
5 participants
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
moderate
|
59 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
none
|
78 participants
|
—
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
mild
|
106 participants
|
—
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
moderate
|
47 participants
|
—
|
|
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
severe
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 6
severe
|
4 participants
|
2 participants
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 6
none
|
154 participants
|
21 participants
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 6
mild
|
88 participants
|
29 participants
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 6
moderate
|
26 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 13
none
|
148 participants
|
—
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 13
mild
|
72 participants
|
—
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 13
moderate
|
19 participants
|
—
|
|
Distribution of Severity of Lumbago During Menstruation at Cycle 13
severe
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Distribution of Severity of Headache During Menstruation at Cycle 6
none
|
187 participants
|
37 participants
|
|
Distribution of Severity of Headache During Menstruation at Cycle 6
mild
|
41 participants
|
4 participants
|
|
Distribution of Severity of Headache During Menstruation at Cycle 6
moderate
|
29 participants
|
11 participants
|
|
Distribution of Severity of Headache During Menstruation at Cycle 6
severe
|
15 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Distribution of Severity of Headache During Menstruation at Cycle 13
none
|
168 participants
|
—
|
|
Distribution of Severity of Headache During Menstruation at Cycle 13
mild
|
38 participants
|
—
|
|
Distribution of Severity of Headache During Menstruation at Cycle 13
moderate
|
30 participants
|
—
|
|
Distribution of Severity of Headache During Menstruation at Cycle 13
severe
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
none
|
251 participants
|
51 participants
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
mild
|
14 participants
|
1 participants
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
moderate
|
4 participants
|
2 participants
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
severe
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
none
|
229 participants
|
—
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
mild
|
11 participants
|
—
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
moderate
|
2 participants
|
—
|
|
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
severe
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=271 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
0
|
202 participants
|
34 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
1
|
52 participants
|
13 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
2
|
11 participants
|
4 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
3
|
2 participants
|
1 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
4
|
2 participants
|
1 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
5
|
2 participants
|
0 participants
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
6
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
2
|
12 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
3
|
2 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
0
|
177 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
1
|
49 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
4
|
2 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
5
|
0 participants
|
—
|
|
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
6
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=272 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
|
-37.2 scores on a scale
Interval -91.0 to 47.0
|
-31.9 scores on a scale
Interval -71.0 to 13.0
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
|
-41.6 scores on a scale
Interval -91.0 to 36.0
|
—
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 6)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=271 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=54 Participants
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)
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
|
6.7 scores on a scale
Interval 0.0 to 80.0
|
12.2 scores on a scale
Interval 0.0 to 83.0
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=242 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
|
6.2 scores on a scale
Interval 0.0 to 65.0
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=326 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=60 Participants
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)
|
|---|---|---|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Reference period 1
|
3.3 number of episodes
Interval 1.0 to 7.0
|
3.4 number of episodes
Interval 1.0 to 7.0
|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Reference period 2
|
3.3 number of episodes
Interval 0.0 to 10.0
|
3.1 number of episodes
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=333 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Reference period 1
|
3.2 number of episodes
Interval 1.0 to 7.0
|
—
|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Reference period 2
|
3.5 number of episodes
Interval 0.0 to 10.0
|
—
|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Reference period 3
|
3.1 number of episodes
Interval 0.0 to 8.0
|
—
|
|
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Reference period 4
|
3.2 number of episodes
Interval 0.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=326 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=60 Participants
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)
|
|---|---|---|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 6
Reference period 1
|
30.7 days
Interval 14.0 to 65.0
|
28.9 days
Interval 13.0 to 65.0
|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 6
Reference period 2
|
19.3 days
Interval 0.0 to 78.0
|
19.9 days
Interval 9.0 to 42.0
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=337 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Reference period 1
|
30.6 days
Interval 14.0 to 65.0
|
—
|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Reference period 2
|
19.8 days
Interval 0.0 to 79.0
|
—
|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Reference period 3
|
21.2 days
Interval 0.0 to 88.0
|
—
|
|
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Reference period 4
|
17.7 days
Interval 0.0 to 69.0
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=341 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=62 Participants
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)
|
|---|---|---|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 1
|
94 participants
|
19 participants
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 2
|
38 participants
|
8 participants
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 3
|
45 participants
|
8 participants
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 4
|
33 participants
|
3 participants
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 5
|
40 participants
|
5 participants
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 6
|
29 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=343 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 1
|
93 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 2
|
38 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 3
|
45 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 4
|
33 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 5
|
41 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 6
|
40 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 7
|
114 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 8
|
24 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 9
|
24 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 10
|
24 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 11
|
21 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 12
|
23 participants
|
—
|
|
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 13
|
31 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=341 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=62 Participants
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)
|
|---|---|---|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 1
|
276 participants
|
54 participants
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 2
|
310 participants
|
57 participants
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 3
|
302 participants
|
58 participants
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 4
|
290 participants
|
54 participants
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 5
|
279 participants
|
54 participants
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 6
|
185 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=343 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 1
|
274 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 2
|
314 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 3
|
307 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 4
|
295 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 5
|
289 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 6
|
285 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 7
|
229 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 8
|
259 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 9
|
245 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 10
|
250 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 11
|
246 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 12
|
243 participants
|
—
|
|
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 13
|
241 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 Participants
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)
|
|---|---|---|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 4
|
87.9 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 5
|
87.8 Percentage of participants
|
80.0 Percentage of participants
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 6
|
92.5 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 1
|
90.3 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 2
|
97.4 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Cycle 3
|
91.1 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 1
|
90.3 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 2
|
97.4 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 3
|
91.1 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 4
|
87.9 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 5
|
87.8 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 6
|
92.5 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 7
|
90.4 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 8
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 9
|
87.5 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 10
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 11
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 12
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Cycle 13
|
90.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (168 days) with 28 days per cyclePopulation: 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)
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 Participants
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)
|
|---|---|---|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 1
|
90.1 Percentage of participants
|
87.0 Percentage of participants
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 2
|
90.8 Percentage of participants
|
94.7 Percentage of participants
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 3
|
91.2 Percentage of participants
|
87.9 Percentage of participants
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 4
|
92.2 Percentage of participants
|
92.6 Percentage of participants
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 5
|
92.7 Percentage of participants
|
88.9 Percentage of participants
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Cycle 6
|
90.9 Percentage of participants
|
88.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 1
|
90.1 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 2
|
90.8 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 3
|
91.2 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 4
|
92.2 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 5
|
92.7 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 6
|
90.9 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 7
|
91.3 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 8
|
91.1 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 9
|
91.0 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 10
|
90.8 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 11
|
91.9 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 12
|
93.8 Percentage of participants
|
—
|
|
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Cycle 13
|
93.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS(Participants with data at Cycle 6)
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=281 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=56 Participants
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)
|
|---|---|---|
|
Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
|
-4.33 Units/mL
Interval -134.8 to 46.1
|
-5.50 Units/mL
Interval -102.6 to 3.2
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=254 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Change in Serum CA-125 From Baseline to Cycle 13
|
-4.66 Units/mL
Interval -135.5 to 90.0
|
—
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS(Participants with data at Cycle 6)
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=281 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=56 Participants
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)
|
|---|---|---|
|
Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
|
0.159 mg/dL
Interval -0.83 to 7.98
|
0.000 mg/dL
Interval -1.62 to 1.37
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=254 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Change in Serum CRP From Baseline to Cycle 13
|
0.014 mg/dL
Interval -0.9 to 1.99
|
—
|
POST_HOC outcome
Timeframe: Baseline and up to Cycle 6 (168 days) with 28 days per cyclePopulation: FAS
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 Participants
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)
|
|---|---|---|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
age: < 30 years
|
-2.4 scores on a scale
Standard Deviation 1.68
|
-2.2 scores on a scale
Standard Deviation 1.64
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
age: >= 30 years
|
-2.2 scores on a scale
Standard Deviation 1.52
|
-2.1 scores on a scale
Standard Deviation 1.69
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
weight: < 50 kg
|
-2.0 scores on a scale
Standard Deviation 1.58
|
-2.3 scores on a scale
Standard Deviation 1.76
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
weight: >= 50kg
|
-2.5 scores on a scale
Standard Deviation 1.61
|
-2.0 scores on a scale
Standard Deviation 1.60
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
functional dysmenorrhea
|
-2.4 scores on a scale
Standard Deviation 1.64
|
-2.3 scores on a scale
Standard Deviation 1.54
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
organic dysmenorrhea
|
-2.0 scores on a scale
Standard Deviation 1.45
|
-1.3 scores on a scale
Standard Deviation 1.91
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
with medical surgical history
|
-2.3 scores on a scale
Standard Deviation 1.61
|
-2.0 scores on a scale
Standard Deviation 1.69
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
without medical surgical history
|
-2.4 scores on a scale
Standard Deviation 1.54
|
-2.4 scores on a scale
Standard Deviation 1.60
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
with previous medication
|
-2.3 scores on a scale
Standard Deviation 1.61
|
-2.1 scores on a scale
Standard Deviation 1.66
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
with pregnancy history
|
-2.2 scores on a scale
Standard Deviation 1.67
|
-2.1 scores on a scale
Standard Deviation 1.68
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
with birth history
|
-2.0 scores on a scale
Standard Deviation 1.71
|
-2.4 scores on a scale
Standard Deviation 1.83
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
total dysmenorrhea score at baseline 3/4
|
-1.9 scores on a scale
Standard Deviation 1.37
|
-1.9 scores on a scale
Standard Deviation 1.37
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
total dysmenorrhea score at baseline 5/6
|
-3.0 scores on a scale
Standard Deviation 1.73
|
-2.6 scores on a scale
Standard Deviation 2.04
|
POST_HOC outcome
Timeframe: Baseline and up to Cycle 13 (364 days) with 28 days per cyclePopulation: FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
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.
Outcome measures
| Measure |
DRSP 3 mg/EE 20 µg (6 Cycles)
n=349 Participants
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)
|
DRSP 3 mg/EE 30 µg (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)
|
|---|---|---|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
age: < 30 years
|
-2.5 scores on a scale
Standard Deviation 1.67
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
age: >= 30 years
|
-2.4 scores on a scale
Standard Deviation 1.70
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
weight: < 50 kg
|
-2.1 scores on a scale
Standard Deviation 1.68
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
weight: >= 50kg
|
-2.7 scores on a scale
Standard Deviation 1.65
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
functional dysmenorrhea
|
-2.6 scores on a scale
Standard Deviation 1.70
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
organic dysmenorrhea
|
-2.1 scores on a scale
Standard Deviation 1.59
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
with medical surgical history
|
-2.5 scores on a scale
Standard Deviation 1.72
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
without medical surgical history
|
-2.5 scores on a scale
Standard Deviation 1.64
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
with previous medication
|
-2.5 scores on a scale
Standard Deviation 1.69
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
with pregnancy history
|
-2.1 scores on a scale
Standard Deviation 1.75
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
with birth history
|
-1.9 scores on a scale
Standard Deviation 1.76
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
total dysmenorrhea score at baseline 3/4
|
-2.0 scores on a scale
Standard Deviation 1.48
|
—
|
|
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
total dysmenorrhea score at baseline 5/6
|
-3.2 scores on a scale
Standard Deviation 1.75
|
—
|
Adverse Events
DRSP 3 mg/EE 20 µg (13 Cycles)
Serious events: 5 serious events
Other events: 335 other events
Deaths: 0 deaths
DRSP 3 mg/EE 30 µg (6 Cycles)
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DRSP 3 mg/EE 20 µg (13 Cycles)
n=355 participants at risk
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 participants at risk
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)
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.28%
1/355 • Number of events 1
|
0.00%
0/65
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.28%
1/355 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.28%
1/355 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Facial palsy
|
0.28%
1/355 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Enteritis infectious
|
0.28%
1/355 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
DRSP 3 mg/EE 20 µg (13 Cycles)
n=355 participants at risk
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)
|
DRSP 3 mg/EE 30 µg (6 Cycles)
n=65 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
14.9%
53/355 • Number of events 68
|
7.7%
5/65 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
13/355 • Number of events 17
|
7.7%
5/65 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
25/355 • Number of events 34
|
3.1%
2/65 • Number of events 2
|
|
Investigations
Blood triglycerides increased
|
8.2%
29/355 • Number of events 33
|
3.1%
2/65 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
5.4%
19/355 • Number of events 20
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
24/355 • Number of events 35
|
4.6%
3/65 • Number of events 3
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
34.9%
124/355 • Number of events 268
|
30.8%
20/65 • Number of events 42
|
|
Nervous system disorders
Headache
|
60.6%
215/355 • Number of events 679
|
60.0%
39/65 • Number of events 81
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.5%
16/355 • Number of events 21
|
6.2%
4/65 • Number of events 7
|
|
Reproductive system and breast disorders
Metrorrhagia
|
27.3%
97/355 • Number of events 235
|
13.8%
9/65 • Number of events 23
|
|
Infections and infestations
Nasopharyngitis
|
51.3%
182/355 • Number of events 339
|
52.3%
34/65 • Number of events 44
|
|
Gastrointestinal disorders
Nausea
|
36.1%
128/355 • Number of events 217
|
38.5%
25/65 • Number of events 37
|
|
Investigations
Plasminogen increased
|
5.1%
18/355 • Number of events 18
|
10.8%
7/65 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
22/355 • Number of events 24
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
22/355 • Number of events 24
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.4%
19/355 • Number of events 20
|
0.00%
0/65
|
|
Immune system disorders
Seasonal allergy
|
9.9%
35/355 • Number of events 38
|
6.2%
4/65 • Number of events 4
|
|
Reproductive system and breast disorders
Breast discomfort
|
3.7%
13/355 • Number of events 15
|
7.7%
5/65 • Number of events 5
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
15.5%
55/355 • Number of events 82
|
16.9%
11/65 • Number of events 11
|
|
Investigations
Protein S decreased
|
2.5%
9/355 • Number of events 9
|
9.2%
6/65 • Number of events 6
|
|
Investigations
Thrombin-antithrombin III complex increased
|
9.9%
35/355 • Number of events 39
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.85%
3/355 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
27.3%
97/355 • Number of events 194
|
21.5%
14/65 • Number of events 26
|
|
Investigations
Coagulation test abnormal
|
19.7%
70/355 • Number of events 71
|
18.5%
12/65 • Number of events 12
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.4%
19/355 • Number of events 25
|
1.5%
1/65 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor will confirm the contents before disclosure.
- Publication restrictions are in place
Restriction type: OTHER