44 Participants Needed

Baclofen Suppositories for Chronic Pelvic Pain

RR
AG
Overseen ByAnkita Gupta, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Louisville
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Baclofen for chronic pelvic pain?

There is some evidence suggesting that topical baclofen, when used in a cream form, may help manage pain in conditions like vulvodynia and proctodynia, which are types of chronic pelvic pain. This suggests that baclofen might have potential benefits for chronic pelvic pain, although more research is needed to confirm its effectiveness in this specific condition.12345

Is baclofen generally safe for humans?

Baclofen is generally used to treat muscle spasms and has been studied for various conditions. However, it can cause serious side effects like central nervous system depression (slowed brain activity), respiratory depression (breathing problems), and withdrawal symptoms if stopped suddenly. These risks are higher with certain methods of administration, like intrathecal (directly into the spinal fluid) use.678910

How is the drug Baclofen unique for treating chronic pelvic pain?

Baclofen is unique for treating chronic pelvic pain because it is administered as a suppository, which allows for localized delivery and potentially fewer systemic side effects compared to oral or intrathecal (spinal) administration. It works by targeting GABA-B receptors, which can help reduce muscle tension and pain.711121314

What is the purpose of this 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.

Research Team

RW

Rodger W Rothenberger, MD

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for women aged 18-65 who have been diagnosed with Chronic Pelvic Pain. It's open to those not sexually active, in same-sex relationships, or using effective contraception. The study aims to see if baclofen suppositories help reduce pelvic pain.

Inclusion Criteria

I am a woman aged between 18 and 65.
I have been diagnosed with chronic pelvic pain.
I am not sexually active, only have same-sex partners, or use effective birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either baclofen or placebo vaginal suppositories nightly for 8 weeks

8 weeks
1 visit (in-person) at 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up questionnaires

4 weeks
2 visits (in-person) at 4 and 12 weeks

Open-label extension (optional)

Participants may opt to continue baclofen suppositories after the main trial

Long-term

Treatment Details

Interventions

  • Baclofen
Trial Overview The study tests if vaginal baclofen suppositories can alleviate chronic pelvic pain compared to a placebo (a treatment without the active drug). Participants are randomly assigned to either the real treatment or placebo and will use it nightly for 8 weeks.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Vaginal baclofen suppositoryActive Control1 Intervention
Baclofen 20mg in Supposibase F vaginal suppository daily per vagina
Group II: Vaginal placebo suppositoryPlacebo Group1 Intervention
Supposibase F vaginal suppository daily per vagina

Baclofen is already approved in United States, Canada, European Union for the following indications:

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Approved in United States as Lioresal for:
  • Severe spasticity of cerebral or spinal origin
  • Multiple sclerosis
  • Traumatic brain injury
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Approved in Canada as Lioresal for:
  • Severe spasticity of cerebral or spinal origin
  • Multiple sclerosis
  • Traumatic brain injury
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Approved in European Union as Lioresal for:
  • Severe spasticity of cerebral or spinal origin
  • Multiple sclerosis
  • Traumatic brain injury

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

Findings from Research

The GaPP2 trial, a multicenter, randomized, double-blind, placebo-controlled study, evaluated the efficacy of gabapentin for treating chronic pelvic pain in women, providing robust evidence from a well-structured clinical trial.
Results indicated that gabapentin did not significantly reduce chronic pelvic pain compared to placebo, suggesting limited efficacy for this condition in the studied population.
Gabapentin not effective for chronic pelvic pain in women.[2021]
A 33-year-old woman with severe vulvar and anal pain, who did not respond to standard treatments, experienced over a 50% reduction in symptoms after 3 months of using a combination of topical baclofen cream and palmitoylethanolamide.
This case suggests that topical baclofen and palmitoylethanolamide may be effective and safer alternatives for managing chronic vulvodynia and proctodynia, potentially avoiding the side effects associated with oral antidepressants and anti-epileptics.
Vulvodynia and proctodynia treated with topical baclofen 5 % and palmitoylethanolamide.Keppel Hesselink, JM., Kopsky, DJ., Sajben, NL.[2020]
In a study of 41 patients with inflammatory chronic pelvic pain syndrome (ICPPS), treatment with finasteride significantly reduced prostatitis symptom severity and prostatism scores compared to placebo, indicating its potential efficacy in managing certain symptoms of ICPPS.
While finasteride did not significantly reduce pain levels compared to placebo, it did lead to notable changes in prostate volume and serum prostate-specific antigen levels, suggesting it may influence prostate-related factors in ICPPS.
Effects of finasteride in patients with inflammatory chronic pelvic pain syndrome: a double-blind, placebo-controlled, pilot study.Leskinen, M., Lukkarinen, O., Marttila, T.[2019]

References

Gabapentin not effective for chronic pelvic pain in women. [2021]
Vulvodynia and proctodynia treated with topical baclofen 5 % and palmitoylethanolamide. [2020]
Effects of finasteride in patients with inflammatory chronic pelvic pain syndrome: a double-blind, placebo-controlled, pilot study. [2019]
Gabapentenoids in pain management in urological chronic pelvic pain syndrome: Gabapentin or pregabalin? [2018]
New directions in the treatment of pelvic pain. [2021]
Combination of baclofen and antimuscarinics to reduce voiding difficulty in treating women with overactive bladders. [2022]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The use of baclosan in the complex therapy of muscle-tonic and myofascial pain syndromes in patients with dorsopathy]. [2016]
Baclofen poisoning in children. [2013]
Baclofen therapeutics, toxicity, and withdrawal: A narrative review. [2023]
Pharmacological complications of the chronic baclofen infusion in the severe spinal spasticity. Personal experience and review of the literature. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Functional aspects of neuroprotective effects of new salts and compositions of baclofen in the convulsive syndrome caused by electroshock. [2019]
Effects of severe spasticity treatment with intrathecal Baclofen in multiple sclerosis patients: Long term follow-up. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of Oral Baclofen in the Treatment of Spasticity in Children and Adolescents With Cerebral Palsy. [2017]
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