CompletedPhase 2

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

United States95 participantsStarted 2005-05

Plain-language 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.

Who can participate

Age range17 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Sexually naïve and agree to abstain from sex during the study * Moderate to severe menstrual-related pelvic pain * Regular spontaneous menstrual cycles Exclusion Criteria: * 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

What they're measuring

Mean Change in Average Severity for Abdominal/Pelvic Pain

Timeframe: Baseline to end of 13-week treatment period

Trial details

NCT IDNCT00196313

SponsorDuramed Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2011-10-12

View on ClinicalTrials.gov More Dysmenorrhea trials