Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Phase 2

Recruiting

• Conditions: Chronic Pelvic Pain Syndrome
• Interventions: Drug: 20 mg baclofen vaginal suppository daily per vagina; Drug: Placebo

• Registration Number: NCT05968937
• Lead Sponsor: University of Louisville

Brief 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.

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

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Study Start: 2024-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal baclofen suppository	20 mg baclofen vaginal suppository daily per vagina	Baclofen 20mg in Supposibase F vaginal suppository daily per vagina
Vaginal placebo suppository	Placebo	Supposibase F vaginal suppository daily per vagina

Primary Outcome Measures

Name	Time	Method
Visual analogue Score (VAS) 1-100 for pain	at 8 weeks of suppository use	VAS is a 1-100mm scale with lower scores indicating less pain

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score	at baseline and at 4, 8 and 12 weeks	Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score is a 40-200 point scale with lower values indicating lower pain interference with quality of life
Pelvic floor impact questionnaire	at baseline and at 4, 8, and 12 week follow up	pelvic floor impact questionnaire is a 0-63 point composite scale consisting of questions concerning bladder/urinary, bowel/rectal, and vaginal/pelvic symptoms with higher values indicating higher symptoms
Pelvic floor disability index (PFDI) questionnaire	at baseline and at 4, 8, and 12 week follow up	the pelvic floor disability index (PFDI) questionnaire is a composite questionnaire on a 0-80 point scale containing questions regarding pelvic organ prolapse, colorectal/anal distress, and urinary distress questions with higher scores indicating higher symptoms
Visual analogue Score (VAS) 1-100 for pain	at baseline and at 4 and 12 week follow up	VAS is a 1-100mm scale with lower scores indicating less pain
O'Leary Sant questionnaire	at baseline and at 4, 8, and 12 week follow up	O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score	at baseline and at 4, 8, and 12 week follow up	Patient-Reported Outcomes Measurement Information System (PROMIS) global health score is a 9-45 point scale with higher scores indicating better overall health and quality of life
Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score	at 0, 4, 8, and 12 week follow up	Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score is a 9-36 point score with higher scores indicating higher bother related to sexual function
Overall Satisfaction	at 4, 8, and 12 week follow up	Overall Satisfaction is a yes/no questionnaire with if "yes" is selected one selects choices from "somewhat" to "quite a bit" in satisfaction. "quite a bit" would indicate greater satisfaction.
Number of other treatments for chronic pelvic pain during the trial period	at 4, 8, and 12 week follow up	Number of other treatments for chronic pelvic pain during the trial period to determine if results are clouded by other, appropriate, evidence based treatments received for chronic pelvic pain.
Pill Count	at 4, 8, and 12 week follow up	Pill Count to determine how many doses of the study medication have been missed

Trial Locations

Locations (1)

ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190; 🇺🇸 Louisville, Kentucky, United States