RecruitingPhase 2NCT05955313

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

Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia


Sponsor

Medical University of Lublin

Enrollment

300 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Naltrexone Hydrochloride for people with naltrexone, quality of life, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaltrexone Hydrochloride

treatment of vulvodynia


Locations(1)

Terpa Limited Liability Company Limited Partnership

Lublin, Poland

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NCT05955313


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