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Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

NCT05955313 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-07-21

No results posted yet for this study

Summary

Vulvodynia (Vd) is chronic functional vulvar pain, with prevalence of 3-16% and unclear etiopathology. Although Vd significantly deteriorates quality of life, the problem is marginalized, no pharmacologic treatment standards exist. Naltrexone hydrochloride is a specific opioid antagonist with slight agonist activity. There is growing body of evidence supporting the effectiveness of low-dose naltrexone (LDN) in different types of chronic pain. The main goal of this trial is to test the effect of LDN on pain perception and quality of life in women with different types of Vd. Half of the study population receives LDN and the remaining patients take placebo, according to randomization list. This RTC is quadruplet blinded.

Conditions

  • Vulvodynia
  • Naltrexone
  • Quality of Life

Interventions

DRUG

Naltrexone Hydrochloride

treatment of vulvodynia

Sponsors & Collaborators

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Ewa Baszak-Radomańska, MD, PhD · Terpa Limited Liability Company Limited partnership

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955313 on ClinicalTrials.gov