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Tests treatment safety and results for Vulvodynia
Official title A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
ClinicalTrials.gov ID: NCT07391241
What this study is testing
What is Pudafensine?
Pudafensine is an investigational medicine, being studied as a potential treatment for vulvodynia.
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
- The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.
- 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 65, women only
You may be able to join if
- Participant with vulvodynia (provoked vestibulodynia).
You likely can't join if
- Women with vulvar pain caused by a specific disorder:
- Infectious (e.g. recurrent candidiasis, herpes).
- Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
- Neoplastic (e.g. Paget disease, squamous cell carcinoma).
- Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
- Trauma (e.g. female genital cutting, obstetrical).
See the full eligibility criteria
- Participant with vulvodynia (provoked vestibulodynia).
- Women with vulvar pain caused by a specific disorder:
- Infectious (e.g. recurrent candidiasis, herpes).
- Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
- Neoplastic (e.g. Paget disease, squamous cell carcinoma).
- Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
- Trauma (e.g. female genital cutting, obstetrical).
- Iatrogenic (e.g. postoperative, chemotherapy, radiation).
- Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea).
- History or current diagnosis of significant pelvic floor dysfunction.
- Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes).
- History or current diagnosis of pelvic inflammatory disease.
- History or current diagnosis of endometriosis.
- History or current diagnosis of interstitial cystitis.
The study team makes the final eligibility decision.
Where it's taking place
- Blackpool, United Kingdom
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blackpool, United Kingdom. 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.