At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
In Brief
A Phase 2 clinical trial evaluating 20 mg baclofen vaginal suppository daily per vagina and Placebo for Chronic Pelvic Pain Syndrome. Completed, enrolled 39 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy
Vaginal suppository composed of Supposibase F daily per vagina