At a glance
ClinicalIndex Comparison Record- ✓Sexually naïve and agree to abstain from sex during the study
- ✓Moderate to severe menstrual-related pelvic pain
- ✓Regular spontaneous menstrual cycles
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets and Placebo tablet for Dysmenorrhea. Completed, enrolled 95 participants across 13 sites.
Detailed 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.
Study Details
Timeline
Interventions
1 tablet daily by mouth
1 tablet daily by mouth