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Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Sponsor: University of Louisville
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.
Official title: Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-01-01
Completion Date
2026-06-01
Last Updated
2025-02-20
Healthy Volunteers
Yes
Conditions
Interventions
20 mg baclofen vaginal suppository daily per vagina
20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy
Placebo
Vaginal suppository composed of Supposibase F daily per vagina
Locations (1)
ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
Louisville, Kentucky, United States