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

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.

Timeline

Start

2023-05-31

Primary completion

2025-12-31

Completion

2026-12-31

Publications

• Background Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pilot study of testing a clinical tool for pelvic physical examination in patients with vulvodynia. Ginekol Pol. 2021 Mar 23. doi: 10.5603/GP.a2020.0168. Online ahead of print.
• Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pelvic floor examination in vulvodynia: VAMP protocol validation in correlation with central sensitization. Womens Health (Lond). 2025 Jan-Dec;21:17455057251338410. doi: 10.1177/17455057251338410. Epub 2025 Jul 1.

Drugs

Indications