NCT00196313

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets	1 tablet daily by mouth
DRUG	Placebo tablet	1 tablet daily by mouth

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-20
• Last updated: 2016-09-22
• Results posted: 2012-05-25

Locations

13 sites across 1 country: United States