Chronic Pelvic Pain SyndromePhase 2NCT05968937
Vaginal Baclofen Suppositories in Chronic Pelvic Pain
A Phase 2 study testing 20 mg baclofen vaginal suppository daily per vagina in people with Chronic Pelvic Pain Syndrome, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- 20 mg baclofen vaginal suppository daily per vagina
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
Louisville, Kentucky, 40205
About this study
Official title: Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
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.
Read the 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:
- 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
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- 20 mg baclofen vaginal suppository daily per vagina, Placebo
- Keywords
- Baclofen, vaginal suppository, pelvic floor muscle dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg baclofen vaginal suppository daily per vaginaDrug
20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy
PlaceboDrug
Vaginal suppository composed of Supposibase F daily per vagina
| Study group | Role | What they receive |
|---|---|---|
| Vaginal baclofen suppository | Active comparator | Baclofen 20mg in Supposibase F vaginal suppository daily per vagina Receives: Drug: 20 mg baclofen vaginal suppository daily per vagina |
| Vaginal placebo suppository | Placebo comparator | Supposibase F vaginal suppository daily per vagina Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue Score (VAS) 1-100 for pain
VAS is a 1-100mm scale with lower scores indicating less pain
Measured: at 8 weeks of suppository use
Secondary outcomes (10)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
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
Measured: at baseline and at 4, 8 and 12 weeks
Pelvic floor impact questionnaire
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
Measured: at baseline and at 4, 8, and 12 week follow up
Pelvic floor disability index (PFDI) questionnaire
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
Measured: at baseline and at 4, 8, and 12 week follow up
Visual analogue Score (VAS) 1-100 for pain
VAS is a 1-100mm scale with lower scores indicating less pain
Measured: at baseline and at 4 and 12 week follow up
O'Leary Sant questionnaire
O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms
Measured: at baseline and at 4, 8, and 12 week follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
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
Measured: at baseline and at 4, 8, and 12 week follow up
Overall Satisfaction
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.
Measured: at 4, 8, and 12 week follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score
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
Measured: at 0, 4, 8, and 12 week follow up
Number of other treatments for chronic pelvic pain during the trial period
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.
Measured: at 4, 8, and 12 week follow up
Pill Count
Pill Count to determine how many doses of the study medication have been missed
Measured: at 4, 8, and 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, double-blinded, placebo-controlled, randomized trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankita Gupta, University of Louisville
- Investigators
- Rodger W Rothenberger, MD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968937
- Sponsor's protocol ID
- 22.1000
- Status last verified
- Apr 2026
- First submitted
- 12 May 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study information will be sourced from the subjects. Identifying information and data collected during this study will be kept secure and confidential. For confidentiality, only research team members will have access to the study information in the database. Subjects will be assigned a unique study ID that will be used on all case report forms and database reporting. The database that will be used is REDCap which is HIPPA (Health Insurance Portability and Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will be maintained in a locked cabinet in a locked office by a member of the research team. The research personnel in this study are CITI and HIPAA trained. If new research personnel are added, an amendment will be submitted to and approved by the IRB before being allowed to participate in the study
Publications
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.
PubMed 27564065Lamvu 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.
PubMed 34128995Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.
PubMed 32080051Mathias 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.
PubMed 8598948Brawn 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.
PubMed 24920437Shafrir 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.
PubMed 34340095Messelink 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.
PubMed 15977259Moldwin 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.
PubMed 23943509Frederice 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.
PubMed 33640993Stone 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.
PubMed 33274514Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.
PubMed 2051498Das 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.
PubMed 27833235Meister 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.
PubMed 30527941Amtmann 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.
PubMed 27175093
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05968937
- Acronym / sponsor ID
- 22.1000
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- Baclofen, vaginal suppository, pelvic floor muscle dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, double-blinded, placebo-controlled, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Vaginal baclofen suppository | Active comparator | Drug: 20 mg baclofen vaginal suppository daily per vaginaBaclofen 20mg in Supposibase F vaginal suppository daily per vagina |
| Vaginal placebo suppository | Placebo comparator | Drug: PlaceboSupposibase F vaginal suppository daily per vagina |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 mg baclofen vaginal suppository daily per vagina20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy | Drug | Vaginal baclofen suppository |
| PlaceboVaginal suppository composed of Supposibase F daily per vagina | Drug | Vaginal placebo suppository |
Primary outcome
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
10 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
Time frame: at baseline and at 4, 8 and 12 weeks
Pelvic floor impact questionnaire
Time frame: at baseline and at 4, 8, and 12 week follow up
Pelvic floor disability index (PFDI) questionnaire
Time frame: at baseline and at 4, 8, and 12 week follow up
Visual analogue Score (VAS) 1-100 for pain
Time frame: at baseline and at 4 and 12 week follow up
O'Leary Sant questionnaire
Time frame: at baseline and at 4, 8, and 12 week follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Time frame: at baseline and at 4, 8, and 12 week follow up
Overall Satisfaction
Time frame: at 4, 8, and 12 week follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score
Time frame: at 0, 4, 8, and 12 week follow up
Number of other treatments for chronic pelvic pain during the trial period
Time frame: at 4, 8, and 12 week follow up
Pill Count
Time frame: at 4, 8, and 12 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 27564065Doggweiler 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.
- Background: PubMed 34128995Lamvu 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.
- Background: PubMed 32080051Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.
- Background: PubMed 8598948Mathias 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.
- Background: PubMed 24920437Brawn 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.
- Background: PubMed 34340095Shafrir 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.
- Background: PubMed 15977259Messelink 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.
- Background: PubMed 23943509Moldwin 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.
- Background: PubMed 33640993Frederice 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.
- Background: PubMed 33274514Stone 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.
- Background: PubMed 2051498Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.
- Background: PubMed 27833235Das 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.
- Individual participant dataSharing planned: No. This study information will be sourced from the subjects. Identifying information and data collected during this study will be kept secure and confidential. For confidentiality, only research team members will have access to the study information in the database. Subjects will be assigned a unique study ID that will be used on all case report forms and database reporting. The database that will be used is REDCap which is HIPPA (Health Insurance Portability and Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will be maintained in a locked cabinet in a locked office by a member of the research team. The research personnel in this study are CITI and HIPAA trained. If new research personnel are added, an amendment will be submitted to and approved by the IRB before being allowed to participate in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodger W Rothenberger, MD study director
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20 mg baclofen vaginal suppository daily per vagina in people with Chronic Pelvic Pain Syndrome, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue Score (VAS) 1-100 for pain (time frame: at 8 weeks of suppository use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968937, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.