Vaginal Baclofen Suppositories in Chronic Pelvic Pain

NCT05968937 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 22.1000
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain Syndrome

Keywords

Baclofen; vaginal suppository; pelvic floor muscle dysfunction

Outcome Measures

Primary Outcomes (1)

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

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

  at 8 weeks of suppository use

Secondary Outcomes (10)

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

  at baseline and at 4, 8 and 12 weeks

• Pelvic floor impact questionnaire

  at baseline and at 4, 8, and 12 week follow up

• Pelvic floor disability index (PFDI) questionnaire

  at baseline and at 4, 8, and 12 week follow up

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

  at baseline and at 4 and 12 week follow up

• O'Leary Sant questionnaire

  at baseline and at 4, 8, and 12 week follow up

Study Arms (2)

Vaginal baclofen suppository

ACTIVE COMPARATOR

Baclofen 20mg in Supposibase F vaginal suppository daily per vagina

Drug: 20 mg baclofen vaginal suppository daily per vagina

Vaginal placebo suppository

PLACEBO COMPARATOR

Supposibase F vaginal suppository daily per vagina

Drug: Placebo

Interventions

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

Vaginal baclofen suppository

Placebo DRUG

Vaginal suppository composed of Supposibase F daily per vagina

Vaginal placebo suppository

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

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

Louisville, Kentucky, 40205, United States

Location

Related Publications (14)

• Doggweiler R, Whitmore KE, Meijlink JM, Drake MJ, Frawley H, Nordling J, Hanno P, Fraser MO, Homma Y, Garrido G, Gomes MJ, Elneil S, van de Merwe JP, Lin ATL, Tomoe H. A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society. Neurourol Urodyn. 2017 Apr;36(4):984-1008. doi: 10.1002/nau.23072. Epub 2016 Aug 26.

  PMID: 27564065 BACKGROUND

• Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.

  PMID: 34128995 BACKGROUND

• Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.

  PMID: 32080051 BACKGROUND

• Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.

  PMID: 8598948 BACKGROUND

• Brawn J, Morotti M, Zondervan KT, Becker CM, Vincent K. Central changes associated with chronic pelvic pain and endometriosis. Hum Reprod Update. 2014 Sep-Oct;20(5):737-47. doi: 10.1093/humupd/dmu025. Epub 2014 Jun 11.

  PMID: 24920437 BACKGROUND

• Shafrir AL, Martel E, Missmer SA, Clauw DJ, Harte SE, As-Sanie S, Sieberg CB. Pelvic floor, abdominal and uterine tenderness in relation to pressure pain sensitivity among women with endometriosis and chronic pelvic pain. Eur J Obstet Gynecol Reprod Biol. 2021 Sep;264:247-253. doi: 10.1016/j.ejogrb.2021.07.029. Epub 2021 Jul 22.

  PMID: 34340095 BACKGROUND

• Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.

  PMID: 15977259 BACKGROUND

• Moldwin RM, Fariello JY. Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. Curr Urol Rep. 2013 Oct;14(5):409-17. doi: 10.1007/s11934-013-0360-7.

  PMID: 23943509 BACKGROUND

• Frederice CP, Brito LGO, Pereira GMV, Lunardi ALB, Juliato CRT. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. Int Urogynecol J. 2021 May;32(5):1087-1096. doi: 10.1007/s00192-021-04725-x. Epub 2021 Feb 27.

  PMID: 33640993 BACKGROUND

• Stone RH, Abousaud M, Abousaud A, Kobak W. A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S110-S120. doi: 10.1002/jcph.1775.

  PMID: 33274514 BACKGROUND

• Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.

  PMID: 2051498 BACKGROUND

• Das S, Palappalllil DS, Purushothaman ST, Rajan V. An Unusual Case of Baclofen Abuse. Indian J Psychol Med. 2016 Sep-Oct;38(5):475-476. doi: 10.4103/0253-7176.191383.

  PMID: 27833235 BACKGROUND

• Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.

  PMID: 30527941 BACKGROUND

• Amtmann D, Kim J, Chung H, Askew RL, Park R, Cook KF. Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain. J Pain Res. 2016 Apr 27;9:251-5. doi: 10.2147/JPR.S93391. eCollection 2016.

  PMID: 27175093 BACKGROUND

Study Officials

• Rodger W Rothenberger, MD

  University of Louisville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, double-blinded, placebo-controlled, randomized trial.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: August 1, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)