Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol

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)