Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Launched by UNIVERSITY OF LOUISVILLE · Jul 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of baclofen vaginal suppositories on women suffering from Chronic Pelvic Pain (CPP). The goal is to see if these suppositories can help relieve their symptoms. Women between the ages of 18 and 65 who are diagnosed with CPP, and are not currently pregnant or breastfeeding, can participate. They should also be able to read and speak English and have no history of serious allergic reactions to the ingredients in the study.

Participants will first complete four short questionnaires to assess their pain levels before being randomly assigned to either receive the baclofen suppositories or a placebo (which looks the same but does not contain baclofen). They will use their assigned treatment each night for 8 weeks and return for follow-up visits at 4 and 8 weeks to fill out the questionnaires again. After the study, participants will have the option to receive a prescription for baclofen suppositories if they find the treatment helpful. Another follow-up will occur at 12 weeks to check on their symptoms. This study is currently recruiting participants, so if you meet the criteria and are interested, you might consider getting involved!

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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