Vulvodynia
Conditions
Brief summary
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.
Interventions
DRUGPudafensine
Pudafensine
Sponsors
Initiator Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant with vulvodynia (provoked vestibulodynia).
Exclusion criteria
* Women with vulvar pain caused by a specific disorder: 1. Infectious (e.g. recurrent candidiasis, herpes). 2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders). 3. Neoplastic (e.g. Paget disease, squamous cell carcinoma). 4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma). 5. Trauma (e.g. female genital cutting, obstetrical). 6. Iatrogenic (e.g. postoperative, chemotherapy, radiation). 7. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test | Through study completion, an average of 1 year |
Countries
United Kingdom
Contacts
CONTACTAbimbola Babajide, Dr, MBCHB
PRINCIPAL_INVESTIGATORAbimbola Babajide, Dr
MAC, UK
Outcome results
None listed