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Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DRSP 3 mg/EE 20 µg (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, Intracyclic bleeding, Drospirenone (DRSP), Ethinylestradiol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 20 years or older at obtaining informed consent
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
  • Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion Criteria:

  • Patients with ovarian chocolate cysts
  • Patients with fibroid needed to be treated
  • Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
  • Patients with undiagnosed abnormal vaginal bleeding
  • Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
  • Patients aged 35 years or older who smoke at least 15 cigarettes per day
  • Patients with migraine accompanied by prodromata
  • Patients with pulmonary hypertension or valvular heart disease
  • Patients who are regularly taking nutritional products that contain St. John's Wort
  • Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
  • Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DRSP 3 mg/EE 20 µg (13 cycles)

DRSP 3 mg/EE 30 µg (6 cycles)

Arm Description

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Outcomes

Primary Outcome Measures

Number of Participants With Intracyclic Bleeding at Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

Secondary Outcome Measures

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.
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
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.
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.
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.
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).
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
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).
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).
Distribution of Severity of Lumbago During Menstruation at Cycle 13
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).
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).
Distribution of Severity of Headache During Menstruation at Cycle 13
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).
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).
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
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).
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.
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.
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).
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).
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).
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).
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
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).
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).
Number of Any Bleeding Days From Cycle 1 to Cycle 6
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).
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).
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
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).
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).
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).
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).
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.
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.
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.
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.

Full Information

First Posted
April 17, 2007
Last Updated
January 22, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00461305
Brief Title
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Official Title
A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Detailed Description
The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles. The trial is sponsored by Bayer Yakuhin, Ltd.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Dysmenorrhea, Intracyclic bleeding, Drospirenone (DRSP), Ethinylestradiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRSP 3 mg/EE 20 µg (13 cycles)
Arm Type
Experimental
Arm Description
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Arm Title
DRSP 3 mg/EE 30 µg (6 cycles)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
DRSP 3 mg/EE 20 µg (13 cycles)
Intervention Description
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Intervention Type
Drug
Intervention Name(s)
DRSP 3 mg/EE 30 µg (6 cycles)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Intracyclic Bleeding at Cycle 6
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
Secondary Outcome Measure Information:
Title
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
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
Title
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
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
Title
Distribution of Total Dysmenorrhea Score at Cycle 6
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
Title
Distribution of Total Dysmenorrhea Score at Cycle 13
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
Title
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
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
Title
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
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
Title
Distribution of Severity of Lumbago During Menstruation at Cycle 6
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
Title
Distribution of Severity of Lumbago During Menstruation at Cycle 13
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
Title
Distribution of Severity of Headache During Menstruation at Cycle 6
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
Title
Distribution of Severity of Headache During Menstruation at Cycle 13
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
Title
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
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
Title
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
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
Title
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
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
Title
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
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
Title
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
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
Title
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
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
Title
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
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
Title
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
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
Title
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
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
Title
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
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
Title
Number of Any Bleeding Days From Cycle 1 to Cycle 6
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
Title
Number of Any Bleeding Days From Cycle 1 to Cycle 13
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
Title
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
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
Title
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
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
Title
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
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
Title
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
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
Title
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
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
Title
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
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
Title
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
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
Title
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
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
Title
Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
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
Title
Change in Serum CA-125 From Baseline to Cycle 13
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
Title
Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
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
Title
Change in Serum CRP From Baseline to Cycle 13
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 years or older at obtaining informed consent Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment Exclusion Criteria: Patients with ovarian chocolate cysts Patients with fibroid needed to be treated Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer Patients with undiagnosed abnormal vaginal bleeding Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases Patients aged 35 years or older who smoke at least 15 cigarettes per day Patients with migraine accompanied by prodromata Patients with pulmonary hypertension or valvular heart disease Patients who are regularly taking nutritional products that contain St. John's Wort Patients who underwent surgical treatment for endometriosis within 2 months prior to screening Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0007
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0011
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-0066
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0024
Country
Japan
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0883
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0021
Country
Japan
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8204
Country
Japan
City
Yamato
State/Province
Kanagawa
ZIP/Postal Code
242-0007
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-0861
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0021
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-0933
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
984-0042
Country
Japan
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-0022
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0061
Country
Japan
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
City
Machida
State/Province
Tokyo
ZIP/Postal Code
194-0022
Country
Japan
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-0003
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
144-0052
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0042
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-0013
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0013
Country
Japan
City
Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
167-0051
Country
Japan
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
City
Osaka
ZIP/Postal Code
530-0013
Country
Japan
City
Osaka
ZIP/Postal Code
534-0014
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

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