Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

NCT ID: NCT00461305

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

DRSP 3 mg/EE 20 µg (13 cycles)

Intervention Type: 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)

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)

Group Type: EXPERIMENTAL

DRSP 3 mg/EE 30 µg (6 cycles)

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Yakuhin, Ltd.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Maebashi, Gunma, Japan

Takasaki, Gunma, Japan

Kobe, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Yamato, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Toyonaka, Osaka, Japan

Chuo-ku, Tokyo, Japan

Hachiōji, Tokyo, Japan

Machida, Tokyo, Japan

Musashino, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Suginami-ku, Tokyo, Japan

Toshima-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 37523477 (View on PubMed)

Other Identifiers

310284

Identifier Type: OTHER

Identifier Source: secondary_id

91616

Identifier Type: -

Identifier Source: org_study_id