Trial Condition(s):
Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea
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
- 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
- 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)
Locations | Status | ||
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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 |
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