drugset / Trial / NCT00196313

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

NCT00196313

Phase 2 Completed 95 enrolled Duramed Research
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-05
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule 0.15 mg Oral
Subject ethinyl estradiol Small molecule 0.03 mg Oral

Indications