Phase II trial studying the efficacy and safety of pudafensine in provoked vestibulodynia
Research type
Research Study
Full title
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)
IRAS ID
1012880
Contact name
Mikael Thomsen
Contact email
Sponsor organisation
Initiator Pharma
Research summary
The purpose of this study is to test a drug Pudafensine (the ‘study drug’) developed by Initiator Pharma for the treatment of Vulvodynia (provoked vestibulodynia). Vulvodynia is defined as vulvar pain without a clear identifiable cause that persists for over 3 months and is classified as a long-lasting, chronic pain condition. The pain associated with vulvodynia may be described as itching, burning, or stabbing and is frequently accompanied by pain during intercourse. Provoked Vestibulodynia is a subclassification defined as provoked pain localised to the vaginal entrance.
Women living with Vulvodynia (provoked vestibulodynia) experience severe pain during everyday activities such as walking, sitting, or wearing tight-fitting pants. Many are unable to use tampons or participate in sexual activities, which profoundly affects their quality of life, intimacy, and relationships. Vulvodynia represents a significant unmet medical need, affecting approximately 10% of females. There are currently no approved medical therapies for Vulvodynia. The treatments used often carry unacceptable side effects and have poorly documented efficacy.
This study aims to assess the safety and tolerability of the study drug, also to see how the body absorbs, removes the study drug, and the effect of the study drug on the body. Pudafensine is a type of drug which restore dopamine in the body and can help pain relief and improve sexual function. It will be administered orally 4 times one to two weeks apart in the study.
This is a cross over double blind study and approximately 34 females with provoked vestibulodynia are planned to be enrolled in the study. Participants will be randomised to receive 2.5, 5.0, 7.5mg of the study drug or placebo over four treatment period. Participants have 75% chance of receiving the study drug at each time during the treatment period. Study participation will last up to 14 weeks.REC name
Wales REC 2
REC reference
25/WA/0243
Date of REC Opinion
30 Oct 2025
REC opinion
Further Information Favourable Opinion