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Recruiting Phase 2 NCT05968937

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Trial Parameters

Condition Chronic Pelvic Pain Syndrome
Sponsor University of Louisville
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 44
Sex FEMALE
Min Age 18 Years
Max Age 65 Years
Start Date 2024-01-01
Completion 2026-01-01
Interventions
20 mg baclofen vaginal suppository daily per vaginaPlacebo

Brief Summary

The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP). Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal suppository without baclofen ingredient). Participants will take their assigned treatment nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when questionnaires will again be completed. Participants may receive additional treatments for CPP during the course of the study. After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms with questionnaires will again occur at 12 weeks.

Eligibility Criteria

Inclusion Criteria: * Women ages 18-65 years old * Women are not sexually active, sexually active with same sex partners or are on effective contraception * Diagnosed with Chronic Pelvic Pain Exclusion Criteria: * Gross hematuria * Currently pregnant or breastfeeding * Unable to speak and read English * History of allergic reaction to baclofen tablet * History of allergic reaction to components of placebo (coconut oil) * History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years

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