To evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in wome

Phase 1

Conditions: Vulvodynia
MedDRA version: 20.0Level: LLTClassification code 10047781Term: VulvodyniaSystem Organ Class: 100000004872
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2022-000245-33-PL

Lead Sponsor: Medical University of Lublin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion
for testing).
2. Patients who are not pregnant and do not plan to become pregnant in the next 9 months from 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 the screening visit and during the entire patient's participation in the study.
9. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.
10. The ability to understand the principles of testing and operating electronic devices.

DETAILED CRITERIA (ASSIGNMENT TO A SUB-GROUP):
1. Fulfillment of one of the following criteria characteristic for individual groups:
i. Provoked vulvodynia: complaints only due to penetration. On the Marinoff scale = 1 point, on the scale (0-3) mostly penetration or no intercourse due to pain.
ii. Mixed vulvodynia: complaints that occur spontaneously and during penetration
iii. Spontaneous vulvodynia: complaints not related to an external factor (it can be cyclical, e.g. related to the menstrual cycle). Monthly pain intensity with daily follow-up NRS = 3, at least 10 days / 28 days.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

MAIN 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 times above 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 screening visit 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. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit.
4. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide).
5. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.
6. 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 the screening visit.
8. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit.
9. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit.
10. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times / year).
11. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders).
12. 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.
13. Pelvic venous diseases (PeVD), 4 criteria met on USG.
14. Pregnancy and lactation.
15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA).
16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety).
17. Significant and / or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.