Vaginal Baclofen Suppositories in Chronic Pelvic Pain
CompletedPhase 2NCT05968937
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
- Conditions
- Interventions
- Drug: 20 mg baclofen vaginal suppository daily per vagina
- Drug: Placebo
- Sponsor
- University of Louisville
- Start date
- 2024-01-01
- Primary completion
- 2026-01-01
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05968937