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

A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents

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.

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