Safety Study of Ethinylestradiol/Drospirenone in Dysmenor... | NCT00461305

ID	Type	Description	Link
310284	Other Identifier	Company Internal

Label	Type	Description	Intervention Names
DRSP 3 mg/EE 20 µg (13 cycles)	Experimental	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)	Drug: DRSP 3 mg/EE 20 µg (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)	Experimental	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)	Drug: DRSP 3 mg/EE 30 µg (6 cycles)

Name	Type	Description	Arm Group Labels	Other Names
DRSP 3 mg/EE 20 µg (13 cycles)	Drug	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)

Measure	Description	Time Frame
Number of Participants With Intracyclic Bleeding at Cycle 6	Intracyclic bleedings were defined as bleedings while a participant takes active tablets.	Up to Cycle 6 (168 days) with 28 days per cycle

Measure	Description	Time Frame
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to 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.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

PubMed Identifier	Type	Citation	Retractions
37523477	Derived	Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

ID	Title	Description
FG000	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)
FG001	DRSP 3 mg/EE 30 µg (6 Cycles)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Intracyclic Bleeding at Cycle 6

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000299 OG00156

Title

Denominators

Categories

Title	Measurements
	OG00040 OG0014

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	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.	Binominal parameter by exact method				Incidence on one treatment arm	13.4			2-Sided	95	9.73	17.77			No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.	No	Superiority or Other

Secondary

Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to 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.

FAS (Participants with data at Cycle 6)

Posted

Number

participants

From baseline up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts

Secondary

Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

From baseline up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Total Dysmenorrhea Score 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.

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Total Dysmenorrhea Score at Cycle 13

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.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Lower Abdominal Pain During Menstruation 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).

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Lumbago During Menstruation 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).

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Lumbago During Menstruation at Cycle 13

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Headache During Menstruation 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).

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Headache During Menstruation at Cycle 13

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Nausea or Vomiting During Menstruation 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).

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation 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.

FAS (Participants with data at Cycle 6)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13

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.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to 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).

FAS (Participants with data at Cycle 6)

Posted

Mean

Full Range

scores on a scale

From baseline up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13

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).

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

scores on a scale

From baseline up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to 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).

FAS (Participants with data at Cycle 6)

Posted

Mean

Full Range

scores on a scale

From baseline up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13

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).

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

scores on a scale

From baseline up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Number of Any Bleeding Episodes From Cycle 1 to Cycle 6

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)

Posted

Mean

Full Range

number of episodes

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Number of Any Bleeding Episodes From Cycle 1 to Cycle 13

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).

FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

number of episodes

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Number of Any Bleeding Days From Cycle 1 to Cycle 6

Posted

Mean

Full Range

days

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Number of Any Bleeding Days From Cycle 1 to Cycle 13

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).

FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

days

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

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)

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6

Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

Posted

Number

participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13

Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6

Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

Posted

Number

Percentage of participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13

Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

Percentage of participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6

Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

Posted

Number

Percentage of participants

Up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants

Secondary

Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13

Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Number

Percentage of participants

Up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to 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.

FAS(Participants with data at Cycle 6)

Posted

Mean

Full Range

Units/mL

From baseline up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Change in Serum CA-125 From Baseline to Cycle 13

CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

Units/mL

From baseline up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Secondary

Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6

CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.

FAS(Participants with data at Cycle 6)

Posted

Mean

Full Range

mg/dL

From baseline up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Secondary

Change in Serum CRP From Baseline to Cycle 13

CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.

FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Full Range

mg/dL

From baseline up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Post-Hoc

Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to 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.

FAS

Posted

Mean

Standard Deviation

scores on a scale

Baseline and up to Cycle 6 (168 days) with 28 days per cycle

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG000

Post-Hoc

Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13

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.

FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)

Posted

Mean

Standard Deviation

scores on a scale

Baseline and up to Cycle 13 (364 days) with 28 days per cycle

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Facility	Status	City	State	ZIP	Country	Contacts
		Nagoya	Aichi-ken	460-0007	Japan

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)			5	355	335	355
EG001	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)			0	65	63	65

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected65 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected65 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected65 at risk
Facial palsy	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected65 at risk
Enteritis infectious	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 events1 affected355 at risk EG0010 events0 affected65 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00068 events53 affected355 at risk EG0016 events5 affected65 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00017 events13 affected355 at risk EG0015 events5 affected65 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00034 events25 affected355 at risk EG0012 events2 affected65 at risk
Blood triglycerides increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG00033 events29 affected355 at risk EG0013 events2 affected65 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00020 events19 affected355 at risk EG0011 events1 affected65 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00035 events24 affected355 at risk EG0013 events3 affected65 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG000268 events124 affected355 at risk EG00142 events20 affected65 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG000679 events215 affected355 at risk EG00181 events39 affected65 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG00021 events16 affected355 at risk EG0017 events4 affected65 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG000235 events97 affected355 at risk EG00123 events9 affected65 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG000339 events182 affected355 at risk EG00144 events34 affected65 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG000217 events128 affected355 at risk EG00137 events25 affected65 at risk
Plasminogen increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG00018 events18 affected355 at risk EG0017 events7 affected65 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00024 events22 affected355 at risk EG0013 events3 affected65 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00024 events22 affected355 at risk EG0014 events4 affected65 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00020 events19 affected355 at risk EG0010 events0 affected65 at risk
Seasonal allergy	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment	EG00038 events35 affected355 at risk EG0014 events4 affected65 at risk
Breast discomfort	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG00015 events13 affected355 at risk EG0015 events5 affected65 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG00082 events55 affected355 at risk EG00111 events11 affected65 at risk
Protein S decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0009 events9 affected355 at risk EG0016 events6 affected65 at risk
Thrombin-antithrombin III complex increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG00039 events35 affected355 at risk EG0011 events1 affected65 at risk
Blood alkaline phosphatase decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0003 events3 affected355 at risk EG0014 events4 affected65 at risk
Genital haemorrhage	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG000194 events97 affected355 at risk EG00126 events14 affected65 at risk
Coagulation test abnormal	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG00071 events70 affected355 at risk EG00112 events12 affected65 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG00025 events19 affected355 at risk EG0011 events1 affected65 at risk

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Title	Description
BG000	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)
BG001	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)
BG002	Total	Total of all reporting groups