RecruitingPhase 2NCT05968937

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial


Sponsor

University of Louisville

Enrollment

44 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

DRUG20 mg baclofen vaginal suppository daily per vagina

20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy

DRUGPlacebo

Vaginal suppository composed of Supposibase F daily per vagina


Locations(1)

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

Louisville, Kentucky, United States

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NCT05968937


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