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

• Status: Completed
• Trial end date: 2008-10-01
• 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 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

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

Details

• Lead Sponsor: Duramed Research
• Treatments: Contraceptive Agents; Contraceptives, Oral; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel

Criteria

Inclusion Criteria:

• Sexually naïve and agree to abstain from sex during the study

• Moderate to severe menstrual-related pelvic pain

• Regular spontaneous menstrual cycles

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

• Treatment with an oral contraceptive within the previous 3 months

• Previous treatment failure with an extended oral contraceptive regimen