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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 21, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT05955313
Lead Sponsor Medical University of Lublin
Conditions
(from sponsor)		 Vulvodynia, Naltrexone, Quality of Life
Related terms Vulvodynia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov