RECRUITING

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05968937

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women ages 18-65 years old
  2. * Women are not sexually active, sexually active with same sex partners or are on effective contraception
  3. * Diagnosed with Chronic Pelvic Pain
  1. * Gross hematuria
  2. * Currently pregnant or breastfeeding
  3. * Unable to speak and read English
  4. * History of allergic reaction to baclofen tablet
  5. * History of allergic reaction to components of placebo (coconut oil)
  6. * History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years

Contacts and Locations

Study Contact

Rodger Rothenberger, MD
CONTACT
5025887663
rwroth03@louisville.edu
Ankita Gupta, MD
CONTACT
5025887663
ankita.gupta@louisville.edu

Principal Investigator

Rodger W Rothenberger, MD
STUDY_DIRECTOR
University of Louisville

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Louisville

  • Rodger W Rothenberger, MD, STUDY_DIRECTOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Baclofen
  • vaginal suppository
  • pelvic floor muscle dysfunction

Additional Relevant MeSH Terms

  • Chronic Pelvic Pain Syndrome