Pilot study of testing a clinical tool for pelvic physical examination in patients with vulvodynia.
Ewa Baszak-Radomanska, Jadwiga Wanczyk-Baszak, Tomasz Paszkowski
https://pubmed.ncbi.nlm.nih.gov/33757151Actively Recruiting
Phase 2
Age: 18Years - 50Years
FEMALE
ID05955313
Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia
Led by Medical University of Lublin · Updated on 2023-07-21
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in women suffering from different types of vulvodynia, a chronic vulvar pain condition with no established pharmacologic treatments. The study is a randomized controlled trial with quadruple blinding, designed to compare the effects of LDN against placebo in women aged 18 to 50 years. Vulvodynia significantly impacts quality of life, and this trial investigates whether LDN can reduce pain and improve emotional well-being over four months of treatment. Participants are randomly assigned to receive either a daily oral dose of 4.5 mg naltrexone hydrochloride or a matching placebo for four months. The trial includes five visits involving a gynecologist, nurse, psychologist, and physiotherapist for diagnosis, screening, randomization, treatment monitoring, and final assessment. The study follows the IMMPACT protocol and includes assessments using validated psychological questionnaires and physical examinations according to the Fascial Manipulation method. During participation, women will record pain levels and quality of life in an electronic diary and complete questionnaires to evaluate emotional functioning and satisfaction with treatment. The study team will monitor tolerability and side effects throughout the treatment period. Follow-up includes a telephone summary visit after treatment completion. The primary outcomes focus on changes in pain intensity, pain type and severity, emotional functioning, and patient satisfaction over four months of treatment.
CONDITIONS
Brief Title
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 50 years at the time of inclusion
- Not pregnant and do not plan to become pregnant within 9 months of study start
- Signed informed and voluntary consent to participate
- General health status with WHO performance 0-2
- Diagnosed with vulvodynia
- Negative drug test at randomization visit
- Documented normal cytology result within the past 3 years
- Stable dose of central nervous system drugs for at least 1 month before screening and during study
- Accept or agree to use a highly effective contraception method throughout the study
- Ability to understand study procedures and use electronic devices
You will not qualify if you...
- Severe liver or kidney dysfunction as defined by specific lab test limits
- Alcohol abuse exceeding 14 units per week or use of other stimulants
- Use of psychoactive drugs except SSRI, SNRI, SARI (Trazodone), or certain anticonvulsants in fixed doses
- Use of opioid drugs within 2 months prior to screening
- Previous use of naltrexone hydrochloride or Mysimba for weight loss
- Botox injection in the vulva within 4 months prior to screening
- Endovascular procedures in the pelvis within 6 months prior to screening
- Surgery requiring general anesthesia within 2 months prior to screening
- Completed multidisciplinary vulvodynia therapy within 4 months prior to screening
- Current vulvar diseases such as lichen, infections, or recurrent genital herpes
- Serious mental disorders except depression or anxiety
- Gynecological abnormalities needing treatment
- Pelvic venous diseases meeting ultrasound criteria
- Pregnancy or breastfeeding
- Spastic diseases like multiple sclerosis or connective tissue disorders
- High anxiety preventing gynecological exam (Lamont scale 3-5)
- Significant uncorrected vision or hearing disability affecting psychological testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 months
Participants receive either low-dose Naltrexone or placebo daily for 4 months to assess its effectiveness in reducing pain and improving quality of life.
4 visits including randomization, control telephone visit, final visit, and telephone summary visit
Trial Site Locations
Total: 1 location
1
Terpa Limited Liability Company Limited Partnership
Lublin, Poland, 20-333
Actively Recruiting
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Research Team
A
Andrzej Stepulak, Professor
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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Published Research Related To This Trial
Pelvic floor examination in vulvodynia: VAMP protocol validation in correlation with central sensitization.
Ewa Baszak-Radomańska, Jadwiga Wańczyk-Baszak, Tomasz Paszkowski
https://pubmed.ncbi.nlm.nih.gov/40590401