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RECRUITING
NCT05955313
PHASE2

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

Sponsor: Medical University of Lublin

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-05-31

Completion Date

2026-12-31

Last Updated

2023-07-21

Healthy Volunteers

No

Interventions

DRUG

Naltrexone Hydrochloride

treatment of vulvodynia

Locations (1)

Terpa Limited Liability Company Limited Partnership

Lublin, Poland