Actively Recruiting
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
Led by Medical University of Lublin · Updated on 2023-07-21
300
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 50 years or up to menopause on the day of inclusion
- Not pregnant and not planning pregnancy in the next 9 months
- Signed informed and voluntary consent to participate
- General health status with WHO score 0-2
- Diagnosis of vulvodynia
- Negative drug test at randomization visit
- Documented normal cytology result within the last 3 years
- Stable dose of central nervous system drugs for at least 1 month before screening and throughout participation
- Acceptance or readiness to use a highly effective contraception method during the study
- Ability to understand study procedures and operate electronic devices
You will not qualify if you...
- Severe liver or kidney dysfunction as defined by specific lab test thresholds
- Alcohol abuse of more than 14 units per week or use of other stimulants
- Use of psychoactive substances except specified medications (SSRI, SNRI, SARI, anticonvulsants) in fixed doses from screening
- Use of opioid drugs in the last 2 months before screening
- Previous use of naltrexone hydrochloride or Mysimba for weight loss at any time
- Botulinum toxin injection in vulva within last 4 months
- Endovascular procedures in small pelvis within last 6 months
- Surgery requiring general anesthesia within last 2 months
- Completed multidisciplinary vulvodynia treatment program within last 4 months
- Vulvar diseases such as lichen, current vulvovaginitis, infections, or recurrent genital herpes
- Current or past serious mental disorders except depression or anxiety
- Gynecological abnormalities needing treatment, including certain lesions and tumors
- Pelvic venous diseases meeting specific ultrasound criteria
- Pregnancy or breastfeeding
- Spastic diseases including multiple sclerosis and connective tissue diseases
- Vaginismus preventing gynecological exam due to anxiety
- Significant uncorrected vision or hearing disability interfering with psychological tests
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Terpa Limited Liability Company Limited Partnership
Lublin, Poland, 20-333
Actively Recruiting
Research Team
A
Andrzej Stepulak, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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