Health TrialsbyHealthPanel

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

ConditionVulvodynia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity of Florida

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 3 months postpartum

Diagnosis of moderate to severe vulvodynia as defined by persistent vulvar pain for at least 3 months duration with an unclear etiology (defined by a minimum pain score at baseline using NRS and VPAQ questionnaires).

Prior therapy may include conservative management options (vulvar care guidelines, vaginal hormone therapy, neuromodulators etc.)

Disqualifiers

Pregnancy or breastfeeding.

Positive urine pregnancy test at study entrance, for subjects of childbearing potential

Unwillingness to use contraception during treatment and for one week after last dose if subject is of childbearing potential and sexually active with males.

Known hypersensitivity to naltrexone.

Trial design

Design model

Single group

Treatments tested in this trial

  • Low Dose Naltrexone

    Drug

    4.5 mg oral LDN daily for four weeks

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Low Dose NaltrexoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Global Impression of Change

Primary outcome is the overall improvement in participant's vulvar pain symptoms as assessed by the Patient Global Impression of Change (PGIC) after four weeks of treatment. It is a single question assessment to measure how much a health condition has changed after treatment. Scale 1-7 (1= best outcome, 7 =worst outcome).

Time frame
4 weeks

Secondary outcomes

1

Numerical Rating Scale

Net change in Numerical Rating Scale (NRS) after four weeks of treatment. NRS allows patients to rate their pain on a scale of 0-10 (0 =no pain, 10= most severe pain).

Time frame
4 weeks
2

Vulvar Pain Assessment Questionnaire

Net change in Vulvar Pain Assessment Questionnaire (VPAQ) after four weeks of treatment. 38 item questionnaire that uses a 5-point Likert Scale (0-4 with 0= no symptoms 4=worst symptoms)

Time frame
4 weeks
3

CSI

Net change in Central Sensitization Inventory (CSI) after four weeks of treatment. Consists of 25 health-related questions with possible responses on a 5-point Likert scale (0-4 with 0=never and 4=always). Total score out of 100 with higher number reflecting a worse outcome.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Mayo Clinic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: