A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

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

Details

• Lead Sponsor: Duramed Research
• Treatments: Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel

Criteria

Inclusion Criteria:

• Moderate to severe menstrual-related pain

• Regular spontaneous menstrual cycles

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

• Treatment with an oral contraceptive in the last 3 months

• Previous treatment failure with an extended oral contraceptive regimen