Trial Condition(s):
Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea
91616
Not Available
Not Available
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