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Muscle Relaxant

Baclofen Suppositories for Chronic Pelvic Pain

Phase 2
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women ages 18-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 4, 8, and 12 week follow up
Awards & highlights

Summary

This trial aims to see if baclofen vaginal suppositories can help improve symptoms of Chronic Pelvic Pain (CPP). Participants will complete questionnaires, then be randomly assigned to either the treatment group (

Who is the study for?
This trial is for women aged 18-65 who have been diagnosed with Chronic Pelvic Pain. It's open to those not sexually active, in same-sex relationships, or using effective contraception. The study aims to see if baclofen suppositories help reduce pelvic pain.
What is being tested?
The study tests if vaginal baclofen suppositories can alleviate chronic pelvic pain compared to a placebo (a treatment without the active drug). Participants are randomly assigned to either the real treatment or placebo and will use it nightly for 8 weeks.
What are the potential side effects?
Possible side effects of baclofen may include drowsiness, weakness, dizziness, headache, seizures, nausea, constipation or urinary retention. However specific side effects related to vaginal administration aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 4, 8, and 12 week follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, 4, 8, and 12 week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Number of other treatments for chronic pelvic pain during the trial period
O'Leary Sant questionnaire
Overall Satisfaction
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vaginal baclofen suppositoryActive Control1 Intervention
Baclofen 20mg in Supposibase F vaginal suppository daily per vagina
Group II: Vaginal placebo suppositoryPlacebo Group1 Intervention
Supposibase F vaginal suppository daily per vagina

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,289 Total Patients Enrolled
Rodger W Rothenberger, MDStudy DirectorUniversity of Louisville
~11 spots leftby Jan 2025
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