Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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)

Participant Flow for 2 periods

Period 1:   Treatment

	DRSP 3 mg/EE 20 µg (13 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
STARTED	355 [1]	65 [1]
Subjects Dispensed Drugs	350	65
Subjects Received Treatment	349 [2]	65 [2]
COMPLETED	254	56
NOT COMPLETED	101	9
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

Period 2:   Continued Treatment

	DRSP 3 mg/EE 20 µg (13 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
STARTED	349 [1]	0 [2]
COMPLETED	254	0
NOT COMPLETED	95	0
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

Reporting Groups

	Description
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)
Total	Total of all reporting groups

Baseline Measures

	DRSP 3 mg/EE 20 µg (13 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)	Total
Number of Participants   [units: participants]	349	65	414
Age   [units: years] Mean ( Full Range )	29.0     ( 20 to 44 )	30.9     ( 20 to 43 )	29.3     ( 20 to 44 )
Gender   [units: participants]
Female	349	65	414
Male	0	0	0
Diagnosis type   [units: participants]
Functional dysmenorrhea	273	53	326
Organic dysmenorrhea	76	12	88
Details of organic dysmenorrhea [1] [units: 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
Average length of menstrual cycle   [units: days] Mean ( Full Range )	29.5     ( 25 to 38 )	29.5     ( 25 to 38 )	29.5     ( 25 to 38 )
Body Mass Index   [units: kg/m^2] Mean ( Full Range )	20.73     ( 16.2 to 29.9 )	20.56     ( 15.3 to 28.7 )	20.70     ( 15.3 to 29.9 )

1.  Primary:

Number of Participants With Intracyclic Bleeding at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

2.  Secondary:

Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

3.  Secondary:

Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

4.  Secondary:

Distribution of Total Dysmenorrhea Score at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

5.  Secondary:

Distribution of Total Dysmenorrhea Score at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

6.  Secondary:

Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

7.  Secondary:

Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

8.  Secondary:

Distribution of Severity of Lumbago During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

9.  Secondary:

Distribution of Severity of Lumbago During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

10.  Secondary:

Distribution of Severity of Headache During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

11.  Secondary:

Distribution of Severity of Headache During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

12.  Secondary:

Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

13.  Secondary:

Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

14.  Secondary:

Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

15.  Secondary:

Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

16.  Secondary:

Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

17.  Secondary:

Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

18.  Secondary:

Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

19.  Secondary:

Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

20.  Secondary:

Number of Any Bleeding Episodes From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

21.  Secondary:

Number of Any Bleeding Episodes From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

22.  Secondary:

Number of Any Bleeding Days From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

23.  Secondary:

Number of Any Bleeding Days From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

24.  Secondary:

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

25.  Secondary:

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

26.  Secondary:

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

27.  Secondary:

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

28.  Secondary:

Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

29.  Secondary:

Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

30.  Secondary:

Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

31.  Secondary:

Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

32.  Secondary:

Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

33.  Secondary:

Change in Serum CA-125 From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

34.  Secondary:

Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

35.  Secondary:

Change in Serum CRP From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

36.  Post-Hoc:

Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6   [ Time Frame: Baseline and up to Cycle 6 (168 days) with 28 days per cycle ]

37.  Post-Hoc:

Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13   [ Time Frame: Baseline and up to Cycle 13 (364 days) with 28 days per cycle ]