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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ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190

Louisville, Kentucky, United States, 40205