Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Study Design/Methodology This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18-65 years old. Eligible, consenting participants will undergo randomization with equal probability of assignment to one of the two groups: 1. Baclofen 20mg vaginal suppository daily per vagina and 2. placebo. Participants will be blinded to study allocation. Baclofen or placebo suppositories will be continued to 8 weeks, at which time all participants will be offered a baclofen suppository prescription. Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires. Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12 weeks of treatment. Participants will be randomized with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic muscle dysfunction and perform pill count. We hypothesize a significant change in PROMIS Pain Interference score, patient satisfaction, PROMIS global health scores, and PROMIS sexual function scores for patients assigned to the baclofen treatment arm. 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