Trial Condition(s):
Dysmenorrhea
Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea
Bayer Identifier:
91616
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Koga Clinic Sendai, Japan, 981-0933 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kakuta Chieko Clinic Sendai, Japan, 984-0042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yazaki Clinic Takasaki, Japan, 370-0883 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Takane Clinic Shinagawa-ku, Japan, 140-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seijo Kinoshita Hospital Setagaya-ku, Japan, 157-0066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kosugi Clinic Setagaya-ku, Japan, 156-0042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Wellness Ginza Clinic Chuo-ku, Japan, 104-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C:z Ladies Clinic Shibuya-ku, Japan, 150-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NS Clinic Hachioji, Japan, 192-0046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Machida Higashiguchi Clinic Machida, Japan, 194-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iida Ladies Clinic Nagoya, Japan, 460-0007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sakie Ladies Clinic Nagoya, Japan, 464-0066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chayamachi Ladies Clinic Osaka, Japan, 530-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawabata Women's Clinic Osaka, Japan, 534-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagaike Clinic Sendai, Japan, 980-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iesaka Clinic Maebashi, Japan, 371-0024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Suzuran Clinic Suginami-ku, Japan, 167-0051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ito Medical Clinic Ota-ku, Japan, 144-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ikebukuro Clinic Toshima-ku, Japan, 171-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kichijyouji Lady's Clinic Musashino, Japan, 180-0003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Luna Clinic Yokohama, Japan, 231-0861 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rinkan Clinic Yamato, Japan, 242-0007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kano's Clinic for Women Nagoya, Japan, 460-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yoshimura Ladies Clinic Toyonaka, Japan, 560-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hanabusa Clinic Kobe, Japan, 650-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kiuchi Ladies Clinic Nishinomiya, Japan, 663-8204 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of participants with intracyclic bleeding at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
Secondary Outcome
- Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 6Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cycle
- Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 13Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cycle
- Distribution of Total Dysmenorrhea Score at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Distribution of Total Dysmenorrhea Score at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Distribution of Severity of lower abdominal pain during menstruation at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Distribution of Severity of lower abdominal pain during menstruation at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Distribution of Severity of lumbago during menstruation at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Distribution of Severity of lumbago during menstruation at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Distribution of Severity of headache during menstruation at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Distribution of Severity of headache during menstruation at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Distribution of Severity of nausea or vomiting during menstruation at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Distribution of Severity of nausea or vomiting during menstruation at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 6Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cycle
- Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 13Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cycle
- Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 6Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cycle
- Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 13Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cycle
- Number of Any Bleeding Episodes from Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Number of Any Bleeding Episodes from Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Number of Any Bleeding Days from Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Number of any bleeding days from Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Number of participants with intracyclic bleeding from Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Number of participants with intracyclic bleeding from Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Number of participants with withdrawal bleeding from Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Number of participants with withdrawal bleeding from Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6Timeframe: Up to Cycle 6 (168 days) with 28 days per cycle
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13Timeframe: Up to Cycle 13 (364 days) with 28 days per cycle
- Change in serum carbohydrate antigen-125 (CA-125) from baseline to Cycle 6Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cycle
- Change in serum CA-125 from baseline to Cycle 13Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cycle
- Change in serum C-reactive protein (CRP) from baseline to Cycle 6Timeframe: From baseline up to Cycle 6 (168 days) with 28 days per cycle
- Change in serum CRP from baseline to Cycle 13Timeframe: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Additional Information
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