Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00461305

First received: April 17, 2007

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Results First Received: September 10, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Dysmenorrhea
Interventions:	Drug: DRSP 3 mg/EE 20 µg (13 cycles) Drug: DRSP 3 mg/EE 30 µg (6 cycles)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

[1]	Enrolled
[2]	FAS, safety population

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

[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

Baseline Characteristics

Hide Baseline Characteristics

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]	Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.

Outcome Measures

Hide All Outcome Measures

1. Primary:

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

Measure Type	Primary
Measure Title	Number of Participants With Intracyclic Bleeding at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	299	56
Number of Participants With Intracyclic Bleeding at Cycle 6 [units: participants]	40	4

Statistical Analysis 1 for Number of Participants With Intracyclic Bleeding at Cycle 6

Groups ^[1]	DRSP 3 mg/EE 20 µg (6 Cycles)
Incidence on one treatment arm ^[2]	13.4
95% Confidence Interval	( 9.73 to 17.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.
[2]	Other relevant estimation information:
	No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.

Statistical Analysis 2 for Number of Participants With Intracyclic Bleeding at Cycle 6

Groups ^[1]	DRSP 3 mg/EE 30 µg (6 Cycles)
Incidence on one treatment arm ^[2]	7.1
95% Confidence Interval	( 1.98 to 17.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Exact 95% confident intervals were calculated using F-distribution by treatment group.
[2]	Other relevant estimation information:
	No text entered.

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 [units: 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

No statistical analysis provided for Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 [units: 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

No statistical analysis provided for Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13

4. Secondary:

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

Measure Type	Secondary
Measure Title	Distribution of Total Dysmenorrhea Score at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Distribution of Total Dysmenorrhea Score at Cycle 6 [units: participants]
0	65	13
1	79	16
2	49	9
3	42	8
4	19	3
5	17	4
6	1	1

No statistical analysis provided for Distribution of Total Dysmenorrhea Score at Cycle 6

5. Secondary:

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

Measure Type	Secondary
Measure Title	Distribution of Total Dysmenorrhea Score at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Distribution of Total Dysmenorrhea Score at Cycle 13 [units: participants]
0	73
1	66
2	41
3	24
4	24
5	13
6	1

No statistical analysis provided for Distribution of Total Dysmenorrhea Score at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 [units: participants]
none	75	14
mild	119	19
moderate	59	16
severe	19	5

No statistical analysis provided for Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 [units: participants]
none	78
mild	106
moderate	47
severe	11

No statistical analysis provided for Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Lumbago During Menstruation at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Distribution of Severity of Lumbago During Menstruation at Cycle 6 [units: participants]
none	154	21
mild	88	29
moderate	26	2
severe	4	2

No statistical analysis provided for Distribution of Severity of Lumbago During Menstruation at Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Lumbago During Menstruation at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Distribution of Severity of Lumbago During Menstruation at Cycle 13 [units: participants]
none	148
mild	72
moderate	19
severe	3

No statistical analysis provided for Distribution of Severity of Lumbago During Menstruation at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Headache During Menstruation at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Distribution of Severity of Headache During Menstruation at Cycle 6 [units: participants]
none	187	37
mild	41	4
moderate	29	11
severe	15	2

No statistical analysis provided for Distribution of Severity of Headache During Menstruation at Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Headache During Menstruation at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Distribution of Severity of Headache During Menstruation at Cycle 13 [units: participants]
none	168
mild	38
moderate	30
severe	6

No statistical analysis provided for Distribution of Severity of Headache During Menstruation at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 [units: participants]
none	251	51
mild	14	1
moderate	4	2
severe	3	0

No statistical analysis provided for Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 [units: participants]
none	229
mild	11
moderate	2
severe	0

No statistical analysis provided for Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	271	54
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 [units: participants]
0	202	34
1	52	13
2	11	4
3	2	1
4	2	1
5	2	0
6	0	1

No statistical analysis provided for Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 [units: participants]
0	177
1	49
2	12
3	2
4	2
5	0
6	0

No statistical analysis provided for Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	272	54
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 [units: scores on a scale] Mean ( Full Range )	-37.2 ( -91 to 47 )	-31.9 ( -71 to 13 )

No statistical analysis provided for Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 [units: scores on a scale] Mean ( Full Range )	-41.6 ( -91 to 36 )

No statistical analysis provided for Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	271	54
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 [units: scores on a scale] Mean ( Full Range )	6.7 ( 0 to 80 )	12.2 ( 0 to 83 )

No statistical analysis provided for Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	242
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 [units: scores on a scale] Mean ( Full Range )	6.2 ( 0 to 65 )

No statistical analysis provided for Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	326	60
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 [units: number of episodes] Mean ( Full Range )
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 )

No statistical analysis provided for Number of Any Bleeding Episodes From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	333
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 [units: number of episodes] Mean ( Full Range )
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 )

No statistical analysis provided for Number of Any Bleeding Episodes From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Number of Any Bleeding Days From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	326	60
Number of Any Bleeding Days From Cycle 1 to Cycle 6 [units: days] Mean ( Full Range )
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 )

No statistical analysis provided for Number of Any Bleeding Days From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Any Bleeding Days From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	337
Number of Any Bleeding Days From Cycle 1 to Cycle 13 [units: days] Mean ( Full Range )
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 )

No statistical analysis provided for Number of Any Bleeding Days From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	341	62
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 [units: 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

No statistical analysis provided for Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	343
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 [units: 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

No statistical analysis provided for Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	341	62
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 [units: 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

No statistical analysis provided for Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	343
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 [units: 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

No statistical analysis provided for Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	349	65
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 [units: 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

No statistical analysis provided for Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	349
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 [units: 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

No statistical analysis provided for Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	349	65
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 [units: 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

No statistical analysis provided for Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	349
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 [units: 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

No statistical analysis provided for Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS(Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	281	56
Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 [units: Units/mL] Mean ( Full Range )	-4.33 ( -134.8 to 46.1 )	-5.50 ( -102.6 to 3.2 )

No statistical analysis provided for Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Change in Serum CA-125 From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	254
Change in Serum CA-125 From Baseline to Cycle 13 [units: Units/mL] Mean ( Full Range )	-4.66 ( -135.5 to 90.0 )

No statistical analysis provided for Change in Serum CA-125 From Baseline to Cycle 13

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 ]

Measure Type	Secondary
Measure Title	Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS(Participants with data at Cycle 6)

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	281	56
Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 [units: mg/dL] Mean ( Full Range )	0.159 ( -0.83 to 7.98 )	0.000 ( -1.62 to 1.37 )

No statistical analysis provided for Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6

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 ]

Measure Type	Secondary
Measure Title	Change in Serum CRP From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	254
Change in Serum CRP From Baseline to Cycle 13 [units: mg/dL] Mean ( Full Range )	0.014 ( -0.90 to 1.99 )

No statistical analysis provided for Change in Serum CRP From Baseline to Cycle 13

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 ]

Measure Type	Post-Hoc
Measure Title	Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
DRSP 3 mg/EE 20 µg (6 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 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)

Measured Values

	DRSP 3 mg/EE 20 µg (6 Cycles)	DRSP 3 mg/EE 30 µg (6 Cycles)
Number of Participants Analyzed [units: participants]	349	65
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 [units: scores on a scale] Mean ± Standard Deviation
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

No statistical analysis provided for Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6

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 ]

Measure Type	Post-Hoc
Measure Title	Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

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)

Measured Values

	DRSP 3 mg/EE 20 µg (13 Cycles)
Number of Participants Analyzed [units: participants]	349
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 [units: scores on a scale] Mean ± Standard Deviation
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

No statistical analysis provided for Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor will confirm the contents before disclosure.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier:	NCT00461305 History of Changes
Other Study ID Numbers:	91616, 310284
Study First Received:	April 17, 2007
Results First Received:	September 10, 2010
Last Updated:	January 22, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

To Top