A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Completed · Phase 2 · Has a placebo group
Conditions studied: Dysmenorrhea
In brief
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.
Key facts
- Study ID
- NCT00196313
- Run by
- Duramed Research
- People needed
- 95
- Starts
- 2005-05-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2016-09-22
Who can join
Age: any, up to 17. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Sexually naïve and agree to abstain from sex during the study
- Moderate to severe menstrual-related pelvic pain
- Regular spontaneous menstrual cycles
You may not qualify if…
- 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
Where it is running
- Duramed Investigational Site — Denver, Colorado, United States
- Duramed Investigational Site — Decatur, Georgia, United States
- Duramed Investigational Site — Louisville, Kentucky, United States
- Duramed Investigational Site — St Louis, Missouri, United States
- Duramed Investigational Site — Cincinnati, Ohio, United States
- Duramed Investigational Site — Cleveland, Ohio, United States
- Duramed Investigational Site — Columbus, Ohio, United States
- Duramed Investigational Site — Medford, Oregon, United States
- Duramed Investigational Site — Philadelphia, Pennsylvania, United States
- Duramed Investigational Site — Pittsburgh, Pennsylvania, United States
- Duramed Investigational Site — Willow Grove, Pennsylvania, United States
- Duramed Investigational Site — Providence, Rhode Island, United States
- Duramed Investigational Site — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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