A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints revised (3)
    • Study description shortened, about 2,619 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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
Trial Details
NCT Number NCT07862400
Lead Sponsor University of Florida
Collaborators: Mayo Clinic
Conditions
(from sponsor)		 Vulvodynia
Related terms Vulvodynia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov