Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

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)

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

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.

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)