Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Description

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.

Conditions

Chronic Pelvic Pain Syndrome

Study Overview

Study Details

Study overview

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.

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

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Condition
Chronic Pelvic Pain Syndrome
Intervention / Treatment

-

Contacts and Locations

Louisville

ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190, Louisville, Kentucky, United States, 40205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Louisville,

Rodger W Rothenberger, MD, STUDY_DIRECTOR, University of Louisville

Study Record Dates

2025-06-01