Vaginal Baclofen Suppositories in Chronic Pelvic Pain

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Louisville
• Treatments: Baclofen

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