Using vaginal baclofen suppositories to treat chronic pelvic pain
Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
This study is testing if baclofen vaginal suppositories can help women aged 18-65 with chronic pelvic pain feel better over 8 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT05968937 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of baclofen vaginal suppositories in alleviating symptoms of Chronic Pelvic Pain (CPP). Women aged 18-65 diagnosed with CPP will be randomly assigned to receive either baclofen or a placebo for 8 weeks. Participants will complete questionnaires to assess pain and quality of life at baseline, 4 weeks, 8 weeks, and 12 weeks. The study aims to determine if baclofen can significantly improve patient-reported outcomes related to pain and overall health.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-65 diagnosed with Chronic Pelvic Pain.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of allergic reactions to baclofen or its components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for women suffering from chronic pelvic pain.
How similar studies have performed: While the use of baclofen for pelvic pain is not widely tested, similar approaches in managing muscle dysfunction have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190 — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Rodger Rothenberger, MD
- Email: rwroth03@louisville.edu
- Phone: 5025887663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.