Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Pelvic Pain Syndrome

In brief

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.

Key facts

Study ID

NCT05968937

Run by

University of Louisville

People needed

39

Starts

2024-01-01

Expected to finish

2026-01-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190 — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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