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

Inclusion Criteria:

1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusionfor testing).
2. Patients who are not pregnant and do not plan to become pregnant in the next 9 monthsfrom the inclusion in the study
3. Signing the patient's informed and voluntary consent to participate in the study.
4. General health of the patient (WHO = 0-2).
5. Diagnosis of vulvodynia.
6. Negative drug test found at the visit randomization.
7. Documented correct cytology result from 3 years ago (before the visit screening).
8. Stable dose of drugs acting on the central nervous system used min. 1 month before thescreening visit and during the entire patient's participation in the study.
9. Acceptance or readiness to use a highly effective method of contraception from thescreening visit throughout the study. Sexual abstinence is not accepted.
10. The ability to understand the principles of testing and operating electronic devices.

Exclusion Criteria:

1. Severe, hepatic and renal dysfunction defined as: i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 timesabove the upper limit of normal - excluding patients with Gilbert's syndrome; iii.EGFR result below 30 ml / min / m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screeningvisit according with point 12 of the Protocol, version 1.0 of March 28, 2022.
2. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Takingpsychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), andanticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from thescreening visit.
3. Taking opioid drugs in the last 2 months before the screening visit (also in OTCpreparations, eg Loperamide).
4. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.
5. BTA injection in the vulva in the last 4 months before the screening visit. 7.Endovascular procedures in the area of the small pelvis in the last 6 months before thescreening visit.
6. Previous surgical procedures requiring general anesthesia (with general anesthesia) inthe last 2 months before the screening visit.
7. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in thelast 4 months before the screening visit.
8. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeastinfections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times /year).
9. Diagnosis of current or past serious mental disorders according to the criteria ofICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxietydisorders).
10. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II / III,pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm,abnormal vaginal inter-cycle bleeding.
11. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15.Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome andmarfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety).
12. Significant and / or uncorrected disability in the field of sight or hearing, making itdifficult to perform psychological tests.