Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMedical University of Lublin
About this trial
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
This trial does not accept healthy volunteersQualifiers
Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing).
Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study
Signing the patient's informed and voluntary consent to participate in the study.
General health of the patient (WHO = 0-2).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Naltrexone Hydrochloride
Drugtreatment of vulvodynia
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: NaltrexoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment effectiveness - change in pain intensity
measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration
Time frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months2
Treatment effectiveness - change in type and severity of pain
measured by McGill Questionnaire (SF-MPQ)
Time frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months3
Treatment effectiveness - change in emotional functioning
Beck Depression Inventory (BDI-II)
Time frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months4
Patient's satisfaction
measured by 11-point Lickert scale
Time frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 monthsSecondary outcomes
1
Treatment tolerability
Assessment of the tolerability of LDN therapy based on the assessment of side effects and adverse events
Time frame
throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov