About this trial
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 criteria
Qualifiers
Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing).
Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study
Signing the patient's informed and voluntary consent to participate in the study.
General health of the patient (WHO = 0-2).
Disqualifiers
Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit.
Trial design
Treatments tested in this trial
- Naltrexone Hydrochloride