BridgeMD
Tests treatment safety and results for Vulvodynia
Official title Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
ClinicalTrials.gov ID: NCT05955313
What this study is testing
What is Naltrexone Hydrochloride?
Naltrexone Hydrochloride is an investigational medicine, being studied as a potential treatment for vulvodynia.
Also referred to as naltrexone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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).
- Diagnosis of vulvodynia.
You likely can't join if
- 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...
- Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI...
See the full eligibility criteria
- 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).
- Diagnosis of vulvodynia.
- Negative drug test found at the visit randomization.
- Documented correct cytology result from 3 years ago (before the visit screening).
- 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.
- Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.
- The ability to understand the principles of testing and operating electronic devices.
- 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...
- 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Lublin, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lublin, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.