Baclofen Suppositories for Chronic Pelvic Pain
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either baclofen or placebo vaginal suppositories nightly for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up questionnaires
Open-label extension (optional)
Participants may opt to continue baclofen suppositories after the main trial
Treatment Details
Interventions
- Baclofen
Baclofen is already approved in United States, Canada, European Union for the following indications:
- Severe spasticity of cerebral or spinal origin
- Multiple sclerosis
- Traumatic brain injury
- Severe spasticity of cerebral or spinal origin
- Multiple sclerosis
- Traumatic brain injury
- 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