Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Purpose
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.
Condition
- Chronic Pelvic Pain Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a single-center, double-blinded, placebo-controlled, randomized trial.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Randomization will be carried out by a computer-based algorithm that will generate study/subject number. This number will correspond with treatment and communicate to The Louisville compounding pharmacy the appropriate drug to distribute without the unblinding of patient or provider. with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization will be stratified based on pelvic muscle tenderness on exam - stratifying by 0-5/10 and 6-10/10 tenderness of pelvic floor musculature on physical exam
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Vaginal baclofen suppository |
Baclofen 20mg in Supposibase F vaginal suppository daily per vagina |
|
|
Placebo Comparator Vaginal placebo suppository |
Supposibase F vaginal suppository daily per vagina |
|
Recruiting Locations
Louisville, Kentucky 40205
More Details
- NCT ID
- NCT05968937
- Status
- Recruiting
- Sponsor
- University of Louisville
Detailed Description
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