Status:
RECRUITING
Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Lead Sponsor:
University of Louisville
Conditions:
Chronic Pelvic Pain Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Study Design/Methodology This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be recruited from a subspecialty clinic at the University of Louisville and be eligi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05968937
Start Date
January 1 2024
End Date
June 1 2026
Last Update
February 20 2025
Active Locations (1)
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1
ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
Louisville, Kentucky, United States, 40205