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

NCT05955313 | Recruiting Phase 2 DMC

• 1 other identifier: VN21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvodynia; Naltrexone; Quality of Life

Keywords

vulvodynia; low dose naltrexone; quality of life

Outcome Measures

Primary Outcomes (4)

• Treatment effectiveness - change in pain intensity

  measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration

  from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months

• Treatment effectiveness - change in type and severity of pain

  measured by McGill Questionnaire (SF-MPQ)

  from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months

• Treatment effectiveness - change in emotional functioning

  Beck Depression Inventory (BDI-II)

  from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months

• Patient's satisfaction

  measured by 11-point Lickert scale

  from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months

Secondary Outcomes (1)

• Treatment tolerability

  throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 months

Study Arms (2)

Naltrexone

EXPERIMENTAL

NALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months

Drug: Naltrexone Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo, coated oral tablets, 1xd.

Drug: Naltrexone Hydrochloride

Interventions

Naltrexone Hydrochloride DRUG

treatment of vulvodynia

Also known as: naltrexone

Naltrexone; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• \. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide).
• \. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.
• \. 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.
• \. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit.
• \. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit.
• \. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times / year).
• \. 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).
• \. 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.
• \. 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).
• \. Significant and / or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Terpa Limited Liability Company Limited Partnership

Lublin, 20-333, Poland

RECRUITING

Related Publications (2)

• Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pilot study of testing a clinical tool for pelvic physical examination in patients with vulvodynia. Ginekol Pol. 2021 Mar 23. doi: 10.5603/GP.a2020.0168. Online ahead of print.

  PMID: 33757151 BACKGROUND

• Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pelvic floor examination in vulvodynia: VAMP protocol validation in correlation with central sensitization. Womens Health (Lond). 2025 Jan-Dec;21:17455057251338410. doi: 10.1177/17455057251338410. Epub 2025 Jul 1.

  PMID: 40590401 DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ewa Baszak-Radomańska, MD, PhD

  Terpa Limited Liability Company Limited partnership

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Stepulak, Professor

CONTACT

448 52 98; cwnr@umlub.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 21, 2023
• Study Start: May 31, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)