Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia
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.
• 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).
• Diagnosis of vulvodynia.
• Negative drug test found at the visit randomization.
• Documented correct cytology result from 3 years ago (before the visit screening).
• Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient's participation in the study.
• Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.
⁃ The ability to understand the principles of testing and operating electronic devices.