A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Public ClinicalTrials.gov record NCT07862400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07862400
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2027 (Estimated)
- Primary completion
- Jul 1, 2027 (Estimated)
- Completion
- Jan 1, 2028 (Estimated)
- Last update posted
- Oct 9, 2026
2027 – 2028
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Florida - Jacksonville | Jacksonville | Florida | 32209 | — |
| Mayo Clinic - Florida | Jacksonville | Florida | 32224 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07862400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 14, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07862400 live on ClinicalTrials.gov.