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Low Dose Naltrexone for Vulvodynia

Not yet recruiting at 1 trial location
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this observational pilot study is to assess the safety, efficacy, and tolerability of oral low dose naltrexone (LDN) in the treatment of vulvodynia. The aims it will address are:

Aim 1:To assess the efficacy of LDN by reviewing patient-reported Global Treatment Improvement scale scores after the 4-week treatment period.

Aim 2: To identify the impact on overall and vulvar pain by calculating the difference between average pre- and post-treatment PGIC, NRS, CSI and VPAQ scores.

Aim 3: To identify adverse effects that patients may experience during treatment to better understand the safety profile of this medication.

Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\]

* Attend a baseline clinic visit and complete PGIC, NRS, VPAQ, and CSI questionnaires

* Take 4.5 mg LDN once daily for 4 weeks

* Discontinue LDN and contact the health care team immediately in the event of adverse effects

* Attend a follow up appointment 4 weeks after medication initiation

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with vulvodynia who are willing to take low dose naltrexone and attend clinic visits. People with certain medical conditions or those unable to safely use naltrexone may not be eligible.

Inclusion Criteria

At least 3 months postpartum
I have tried conservative treatments like vulvar care or hormone therapy.
I have had ongoing vulvar pain for at least 3 months with no clear cause.

Exclusion Criteria

Pregnancy or breastfeeding
Positive toxicology screen for opioids at study entrance
I currently have an active gynecologic cancer.
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • Low Dose Naltrexone

Trial Overview

The study tests if taking a daily low dose (4.5 mg) of oral naltrexone for 4 weeks helps reduce pain from vulvodynia. Participants complete questionnaires before and after treatment to measure changes in symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Low Dose NaltrexoneExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

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