RecruitingPHASE2INTERVENTIONAL

A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)

This study is looking into a new medication called pudafensine for a condition called vulvodynia, specifically provoked vestibulodynia. This condition causes ongoing pain in the outer female reproductive organs, often when touched. The study is in its second phase, meaning it's checking both how well the medicine works and if it's safe to use. Patients will receive either the actual medicine or a dummy treatment (placebo) in a way that neither they nor their doctors know which they're getting. This helps us truly understand the medicine's effects. The main goal is to find out if pudafensine can help reduce the pain associated with vulvodynia, and to monitor for any side effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Initiator Pharma

Enrolment target

Start

17 Dec 2025

Estimated completion

01 Dec 2026

Vulvodynia

What is this study about?

This study is focused on understanding a new medication called pudafensine for a condition known as vulvodynia, specifically a type called provoked vestibulodynia. Vulvodynia is a long-lasting pain or discomfort in the outer female reproductive organs (the vulva) that can last for at least three months without a clear cause. In provoked vestibulodynia, this pain is usually triggered by touch or pressure, for example, during sexual activity, tampon insertion, or even tight clothing. It can be a very challenging condition to live with, affecting daily life and relationships.

The main purpose of this study is to find out if pudafensine is a safe and effective treatment for this type of vulvodynia. We want to see if it can help reduce the pain women experience. This is a "Phase 2" study, which means we're still in the earlier stages of drug development. We're looking closely at the right dose, how well it works, and any potential side effects.

To make sure the results are fair and accurate, the study uses a special design. Some participants will receive the actual medicine, while others will receive a 'placebo' – a dummy treatment that looks just like the real medicine but contains no active ingredients. Neither the participants nor their doctors will know who is getting what until after the study is complete. This helps us compare the effects of pudafensine against no active treatment, giving us a clearer picture of its true benefits.

Key takeaways

This study is testing a new medicine (pudafensine) for vulvodynia where pain is triggered by touch.
It's a Phase 2 study, checking both effectiveness and safety.
Participants will randomly receive either the medicine or a dummy treatment (placebo).
The study aims to see if pudafensine can reduce vulvar pain.
You can't join if your vulvar pain is caused by certain other medical conditions.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for women between the ages of 18 and 65 who have been diagnosed with a specific type of vulvar pain called vulvodynia (provoked vestibulodynia). This means your pain is mainly when your vulva is touched or pressed.

However, you won't be able to join if your vulvar pain is caused by other specific medical issues. For example, if your pain comes from infections like thrush or herpes, ongoing skin conditions like lichen sclerosus, certain cancers, nerve problems, injuries from trauma, or hormonal issues like dryness due to menopause, this study isn't suitable for you. Also, if you have other ongoing pelvic pain conditions like endometriosis, interstitial cystitis (a bladder condition), or problems with your pelvic floor muscles, you won't be eligible. This is to make sure we're studying the specific effects of the new medicine on vulvodynia.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 65 years old?
Have you been diagnosed with vulvodynia where pain is triggered by touch?
Is your vulvar pain NOT caused by an infection (like thrush or herpes)?
Is your vulvar pain NOT caused by a skin condition (like lichen sclerosus)?
Do you NOT have other ongoing pelvic pain conditions like endometriosis or interstitial cystitis?
Do you NOT have significant problems with your pelvic floor muscles?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given study medication (either pudafensine or a placebo) to take. The study is designed so that both you and your study doctor will not know whether you are receiving the active drug or the placebo. You will have several visits to the study clinic where the medical team will monitor your health, ask about your pain levels, and check for any side effects. You might also have physical examinations. The total duration of your involvement in the study, including follow-up visits, will be explained in detail by the study team. They will inform you about the number of doses, frequency of visits, and overall time commitment, but generally, studies like this involve regular check-ups over several weeks or months to track your progress and safety.

Potential risks and benefits

Taking part in this study might offer a potential benefit if pudafensine helps reduce your vulvar pain. However, there's no guarantee the treatment will work for you, and you might receive a placebo. Like all medications, pudafensine could have side effects, which the study team will monitor closely. You will be fully informed about all known risks before you agree to participate. It's very important to remember that participating is entirely your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

MAC
Verified postcode
Blackpool, United Kingdom· Recruiting

Common questions

What is vulvodynia?

Vulvodynia is ongoing pain or discomfort in the outer female reproductive organs (the vulva) that lasts for at least three months, without a clear cause like an infection. This study focuses on a type where pain is triggered by touch.

What is pudafensine?

Pudafensine is a new medicine being tested to see if it can help reduce the pain associated with vulvodynia. It's not yet approved for general use.

What does 'Phase 2 Study' mean?

A Phase 2 study means the new medicine is being tested in a small group of people to see if it works and to check its safety, after initial safety tests have been done. It's an earlier stage of drug development.

Will I definitely get the new medicine?

No, this is a 'randomised, double-blind, placebo-controlled' study. This means you will randomly receive either pudafensine or a dummy treatment (placebo), and neither you nor your doctor will know which one you are getting during the study.

Why can't people with other conditions participate?

The study needs to be very clear about how pudafensine specifically affects vulvodynia. Having other conditions could make it harder to tell if the medicine is working for the vulvodynia pain itself, rather than for another pain source.

How to find out more

Abimbola Babajide, Dr, MBCHB

abimbolababajide@macplc.com +44 01253444451 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.