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 range

17 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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