NCT05955313 Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
| NCT ID | NCT05955313 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Lublin |
| Condition | Vulvodynia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2023-05-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ewa Baszak-Radomańska, MD, PhD
PRINCIPAL INVESTIGATOR
Terpa Limited Liability Company Limited partnership
Frequently Asked Questions
Who can join the NCT05955313 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Vulvodynia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05955313 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05955313 currently recruiting?
Yes, NCT05955313 is actively recruiting participants. Contact the research team at cwnr@umlub.pl for enrollment information.
Where is the NCT05955313 trial being conducted?
This trial is being conducted at Lublin, Poland.
Who is sponsoring the NCT05955313 clinical trial?
NCT05955313 is sponsored by Medical University of Lublin. The principal investigator is Ewa Baszak-Radomańska, MD, PhD at Terpa Limited Liability Company Limited partnership. The trial plans to enroll 300 participants.