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Completed

NCT Number: NCT05968937

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

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.

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Key information

Conditions

Chronic Pelvic Pain Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190

Louisville, Kentucky, 40205, United States

About this study

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:

  • Baclofen 20mg vaginal suppository daily per vagina and
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20 mg baclofen vaginal suppository daily per vagina

Drug

20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy

Placebo

Drug

Vaginal suppository composed of Supposibase F daily per vagina

Primary outcomes

  1. Visual analogue Score (VAS) 1-100 for pain

    Time frame: at 8 weeks of suppository use

    VAS is a 1-100mm scale with lower scores indicating less pain

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score

    Time frame: 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

  2. Pelvic floor impact questionnaire

    Time frame: 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

  3. Pelvic floor disability index (PFDI) questionnaire

    Time frame: 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

  4. Visual analogue Score (VAS) 1-100 for pain

    Time frame: at baseline and at 4 and 12 week follow up

    VAS is a 1-100mm scale with lower scores indicating less pain

  5. O'Leary Sant questionnaire

    Time frame: 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

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) global health score

    Time frame: 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

  7. Overall Satisfaction

    Time frame: 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.

  8. Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score

    Time frame: 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

  9. Number of other treatments for chronic pelvic pain during the trial period

    Time frame: 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.

  10. Pill Count

    Time frame: at 4, 8, and 12 week follow up

    Pill Count to determine how many doses of the study medication have been missed

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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