Baclofen Suppositories for Chronic Pelvic Pain

Overseen By Ankita Gupta, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Louisville

Disqualifiers: Pregnancy, Breastfeeding, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

44 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 11 12 13 14}

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

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

Group I: Vaginal baclofen suppository Active Control 1 Intervention

Baclofen 20mg in Supposibase F vaginal suppository daily per vagina

Group II: Vaginal placebo suppository Placebo Group 1 Intervention

Supposibase F vaginal suppository daily per vagina

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

Approved in United States as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

Approved in Canada as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

Approved in European Union as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 119 men aged 18-50 with chronic pelvic pain, gabapentin was found to be significantly more effective than pregabalin, with 76% of gabapentin users reporting at least a 50% improvement in pain compared to only 40% of pregabalin users.

Patients on pregabalin were more likely to require additional medication (like amitriptyline) for pain management, with 44% needing it compared to just 13.6% of those on gabapentin, indicating that gabapentin may provide better pain relief on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentenoids in pain management in urological chronic pelvic pain syndrome: Gabapentin or pregabalin? Agarwal, MM., Elsi Sy, M.[2018]

Chronic pelvic pain treatment is complex and typically involves a combination of behavioral, medical, and procedural therapies, reflecting the multifaceted nature of the condition.

Recent advancements in understanding the neurobiology of chronic pelvic pain have led to the exploration of new treatment options, including neuromodulatory therapies and complementary medicine, alongside traditional focal therapies for specific pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in the treatment of pelvic pain. Udoji, MA., Ness, TJ.[2021]

In a study of 245 women with overactive bladder (OAB), the combination of baclofen with antimuscarinics significantly reduced the occurrence of voiding difficulty in those with abnormal voiding patterns compared to those with normal patterns.

After adding baclofen, the difference in voiding difficulty between women with abnormal and normal voiding patterns was eliminated, suggesting that baclofen enhances the efficacy of antimuscarinics in treating OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of baclofen and antimuscarinics to reduce voiding difficulty in treating women with overactive bladders. Chin, HY., Lin, KC., Chiang, CH., et al.[2022]

In a study involving 20 patients with lumbar spine pain, baclosan (baclofen) significantly reduced pain intensity and muscle tension when added to traditional therapy over a 4-week period.

Patients taking baclosan also showed improvements in motor function and emotional well-being compared to a control group receiving only basic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of baclosan in the complex therapy of muscle-tonic and myofascial pain syndromes in patients with dorsopathy]. Batysheva, TT., Boĭko, AN., Zaĭtsev, KA., et al.[2016]

In a report of six cases of acute baclofen overdose in children, all patients exhibited central nervous system depression and respiratory issues, highlighting the drug's potential dangers.

All children responded well to supportive management, but the report stresses the importance of educating caregivers on safe drug storage and disposal to prevent such overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baclofen poisoning in children. Cooke, DE., Glasstone, MA.[2013]

Baclofen is effective for treating spasticity in conditions like multiple sclerosis and spinal cord injuries, but it is also increasingly used off-label for issues like musculoskeletal pain and alcohol use disorder.

While baclofen can be beneficial, it carries risks of serious complications, especially with intrathecal administration, necessitating careful monitoring and supportive management for toxicity and withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baclofen therapeutics, toxicity, and withdrawal: A narrative review. Romito, JW., Turner, ER., Rosener, JA., et al.[2023]

In a study of 25 patients receiving chronic intrathecal baclofen infusion for spinal spasticity, minor side effects were observed in a small percentage, including hypotonia (12%), erectile impairment (8%), and constipation (4%), indicating that while side effects can occur, they are generally manageable.

Serious complications like overdose and withdrawal syndrome were not observed in this patient group, suggesting that with proper monitoring, the risks associated with this therapy are low, and it should be administered in specialized centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological complications of the chronic baclofen infusion in the severe spinal spasticity. Personal experience and review of the literature. Dario, A., Scamoni, C., Picano, M., et al.[2019]

In a study of 66 patients undergoing open hemorrhoidectomy, topical baclofen cream (5%) significantly reduced postoperative pain compared to a placebo, with lower pain scores reported at one and two weeks after surgery.

Patients using baclofen also required less analgesic medication, indicating its efficacy in managing pain with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial. Ala, S., Alvandipour, M., Saeedi, M., et al.[2021]

New salts of baclofen combined with organic carbonic acids showed neuroprotective and anticonvulsive effects in animal studies, effectively reducing convulsive symptoms and postconvulsive disorders.

Baclofen analogs with citrate, and to a lesser extent glutamate and glycine, demonstrated significantly greater activity compared to the original baclofen, suggesting enhanced therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional aspects of neuroprotective effects of new salts and compositions of baclofen in the convulsive syndrome caused by electroshock. Tyurenkov, IN., Borodkina, LE., Bagmetova, VV.[2019]

In a study of 14 MS patients, intrathecal Baclofen significantly reduced severe spasticity in the lower limbs over a long-term follow-up of up to 76 months, with the most notable improvement occurring within the first year.

The initial Baclofen dosage was adjusted from 136.2 μg to 228.6 μg after 12 months, but no further significant dosage changes were needed, indicating sustained efficacy with minimal adjustments required after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of severe spasticity treatment with intrathecal Baclofen in multiple sclerosis patients: Long term follow-up. Stampacchia, G., Gerini, A., Mazzoleni, S.[2018]

A systematic review of six studies involving 130 children and adolescents with spastic cerebral palsy found conflicting evidence regarding the effectiveness of oral baclofen in reducing muscle tone or improving motor function.

The overall quality of the studies was low, with significant risks of bias and inconsistencies, leading to insufficient data to conclusively support or refute the use of oral baclofen for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Oral Baclofen in the Treatment of Spasticity in Children and Adolescents With Cerebral Palsy. Navarrete-Opazo, AA., Gonzalez, W., Nahuelhual, P.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Gabapentin not effective for chronic pelvic pain in women. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Vulvodynia and proctodynia treated with topical baclofen 5 % and palmitoylethanolamide. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of finasteride in patients with inflammatory chronic pelvic pain syndrome: a double-blind, placebo-controlled, pilot study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Gabapentenoids in pain management in urological chronic pelvic pain syndrome: Gabapentin or pregabalin? [2018]

5. England pubmed.ncbi.nlm.nih.gov

New directions in the treatment of pelvic pain. [2021]

6. Singapore pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Baclofen poisoning in children. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Baclofen therapeutics, toxicity, and withdrawal: A narrative review. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Pharmacological complications of the chronic baclofen infusion in the severe spinal spasticity. Personal experience and review of the literature. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Functional aspects of neuroprotective effects of new salts and compositions of baclofen in the convulsive syndrome caused by electroshock. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of severe spasticity treatment with intrathecal Baclofen in multiple sclerosis patients: Long term follow-up. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Oral Baclofen in the Treatment of Spasticity in Children and Adolescents With Cerebral Palsy. [2017]