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

Completed · Phase 3 · 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 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Key facts

Study ID

NCT00196365

Run by

Duramed Research

People needed

97

Starts

2005-01-01

Expected to finish

2007-07-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe menstrual-related pain
• Regular spontaneous menstrual cycles

You may not qualify if…

• Any contraindication to the use of oral contraceptives
• Treatment with an oral contraceptive in the last 3 months
• Previous treatment failure with an extended oral contraceptive regimen

Where it is running

• Duramed Investigational Site — Huntsville, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Tampa, Florida, United States
• Duramed Investigational Site — Decatur, Georgia, United States
• Duramed Investigational Site — Moorestown, New Jersey, United States
• Duramed Investigational Site — Charlotte, North Carolina, United States
• Duramed Investigational Site — Columbus, 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 — Memphis, Tennessee, United States
• Duramed Investigational Site — Salt Lake City, Utah, United States
• Duramed Investigational Site — Newport News, Virginia, United States
• Duramed Investigational Site — Norfolk, Virginia, United States
• Duramed Investigational Site — Spokane, Washington, United States
• Duramed Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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