Testing low-dose naltrexone for vulvodynia pain relief

Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia

This study is testing if low-dose naltrexone can help women with vulvodynia feel less pain and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Medical University of Lublin (Academic / other)
• Locations: 1 site (Lublin)
• Trial ID: NCT05955313 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of low-dose naltrexone (LDN) in reducing chronic pain and improving quality of life in women suffering from different types of vulvodynia. The study is a randomized controlled trial with a quadruplet-blinded design, where participants are assigned to receive either LDN or a placebo over a period of four months. Participants will undergo multiple assessments, including pain perception and quality of life evaluations, using validated questionnaires and e-diaries. The trial aims to provide insights into the potential benefits of LDN for this marginalized condition.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 50 who have been diagnosed with vulvodynia and meet specific health criteria.

Not a fit: Patients with severe hepatic conditions or those who are pregnant or planning to become pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could offer a new pharmacological treatment option for women suffering from vulvodynia, significantly improving their quality of life.

How similar studies have performed: There is a growing body of evidence supporting the effectiveness of low-dose naltrexone in treating chronic pain, suggesting that this approach may yield positive results.

Eligibility 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.

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.

Where this trial is running

Lublin

• Terpa Limited Liability Company Limited Partnership — Lublin, Poland (Recruiting)

Study contacts

• Principal investigator: Ewa Baszak-Radomańska, MD, PhD — Terpa Limited Liability Company Limited partnership
• Study coordinator: Andrzej Stepulak, Professor

Conditions Vulvodynia; Naltrexone; Quality of Life; vulvodynia; low dose naltrexone; quality of life