Vulvodynia MedDRA version: 20.0 Level: LLT Classification code 10047781 Term: Vulvodynia System Organ Class: 100000004872
Conditions
Interventions
Product Name: naltrexone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentra
Sponsors
Medical University of Lublin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effectiveness of LDL in reducing chronic pain and improvement of quality of life in women with provoked, spontaneous and mixed vulvodynia assessed on the basis of the test results recommended according to IMMPACT, compared to the placebo arm;Secondary Objective: Assessment of the tolerability of LDN therapy based on the assessment of side effects compared to the placebo arm;Primary end point(s): The efficacy of LDN in reducing chronic pain as assessed by the test results recommended in the IMMPACT agreement: 1. Pain Assessment: a) Change in pain intensity on an 11-point NRS scale based on spontaneous sensation of vulvovaginal pain and during vaginal penetration during sexual intercourse from baseline (VISIT 1) to final visit (VISIT 4) in the eDiaries in daily follow-up (from VISIT 1 to VISITS 4) and after the completion of treatment at VISIT 5, by telephone. The change in the quality and intensity of pain will also be assessed according to the McGill Questionnaire (SF-MPQ) and the CSI from pre-treatment values ??(VISIT 2) to end-of-treatment visit (VISIT 4). 2. Assessment of physical functioning on the basis of psychological tests performed during VISIT 2 and VISIT 4: a) Change in general functioning on the basis of the SF-36 quality of life questionnaire. b) Change in sexual functioning, satisfaction, suffering in connection with intercourse according to female sexual function index FSFI - Female sexual function index and pl-FSDS - Female sexual distress scale. c) Change in sexual satisfaction based on the Sexual Satisfaction Scale (Davies 2006). 3. Assessment of emotional functioning from the initial value (VISIT 2) to the final visit (VISIT 4): a) Changing the severity of depression using the Beck Depression Inventory - Second Edition; BDI-II. b) Change in anxiety severity using the state anxiety inventory and trait anxiety (STAI). 4. Patient's assessment of improvement in health and satisfaction with treatment: using an 11-poin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Tolerance of LDN therapy (assessment of side effects and vital signs) 2.Validation of the physical examination of the pelvis (VAMP protocol) in women with vulvodynia (assessed during W 1,2,4) 3. Assessment of psychological characteristics, physiotherapeutic diagnosis and LDN treatment outcomes, from baseline (W 2) to final visit (W 4) in vulvodynia subgroups (provoked, spontaneous and mixed) 4. Assessment of the improvement in the quality of life with the use of LDN in women with many types of chronic pain (based on the Central Sensitization Questionnaire) and in the field of coexisting diseases with vulvodynia (irritable bowel syndrome, fibromyalgia) and urinary incontinence using: IBS Symptoms Scale (IBS Symptoms) Severity Score - IBS-SSS), Irritable Bowel Syndrome IBS-QoL, King's Questionnaire: The KHQ and Fibromyalgia Questionnaire acc. ACR 2010, (from W1 to W 4 and during the summary visit by telephone W 5). 5. Developing the principles of diagnosing women with vulvodynia (interview, gynecological examination and physiotherapeutic evaluation) - throughout the entire examination. 6.Identification of patients' psychological characteristics that affect the effectiveness of LDN treatment, based on: evaluation of depression using the Beck Depression Inventory - Second Edition (BDI-II), evaluation of anxiety using the state and trait anxiety inventory (STAI) (W 2, 4) and the T.E.C trauma questionnaire (W2). 7. Examination of patients with vulvodynia according to the principles of Fascia Manipulation (CFMS) L. Stecco and the Beighton scale as well as the assessment of the influence of LDN on myofascial markers in patients with vulvodynia (W2, 4). Number of patients with adverse events (AEs) and serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: 1. V2-V5 2. V1, V2, V4 3. V2 to V4 4. V2 to V5 5. throughout the study 6. V2 and V4 7. V2 and V4 | — |
Countries
Poland
Contacts
Public ContactPrincipal Investigator
Terpa Limited Liability Company Limited partnership
Outcome results
None listed