Mac's Vulvodynia Research

Teresa Cullen – Researcher

Introduction:

Vulvodynia affects millions of women, yet it remains underdiagnosed and often misunderstood. Many people live with the pain for years without a diagnosis or answers. Right now, there are no approved treatments in the UK specifically for vulvodynia, which is why research like this is so important. By taking part in clinical trials, volunteers help scientists understand what does and doesn’t work and help move us closer to real solutions.

Q1: Can you explain what the medication being researched is and how it works?

Answer: The study medication is a novel therapy called Pudafensine. It’s designed to increase dopamine, a natural chemical in the body that helps regulate pleasure and pain. In conditions like vulvodynia, pain pathways can become oversensitive; researchers believe that this study medication may “turn down the volume” on these pain signals so daily activities (and intimate ones) become more comfortable.

Q2: Why target dopamine for vulvodynia relief?

Answer: Dopamine plays a role in how the brain processes pain signals. People with chronic pain conditions often have lower dopamine activity. By increasing dopamine, this medication may help calm pain pathways and ultimately improve quality of life. It’s being researched for other conditions too.

Q3: What should volunteers expect during the trial?

Answer: The trial will last between 61 and 98 days (this will depend on your menstrual cycle) and involves 7 visits to one of MAC’s clinics in either Lancashire or Greater Manchester. These visits include health checks, questionnaires about symptoms, some intimate tests, and taking the study medication (or placebo) as an oral capsule.

Q4. What happens during the intimate tests, and why are they required?

During the study, a few intimate tests are carried out to confirm the correct diagnosis, measure pain consistently, track changes over time, and ensure your safety. Your privacy and comfort are always prioritised, and you can request a female clinician or female chaperone at any point.

1. Wagner Test

A clinician gently touches small areas on the vulva with a soft cotton swab attached to a device that will measure the pressure. You simply say when you begin to feel discomfort or pain. This helps identify sensitivity and measure how your pain changes throughout the trial.

Modesty and comfort:

- You will be given a gown to preserve modesty.

- You can pause the test at any time.

- The room where the test is conducted is completely private.

2. Tampon Test

This test is completed in private in an en-suite bathroom. You will be asked to insert a standard tampon and then remove it immediately and rate the overall pain on a scale of 0-10. Because provoked vulvodynia often causes pain on insertion, this provides a real‑life, repeatable way to track whether the investigational medication is helping.

Modesty and comfort:

- Done entirely in private by yourself, at your own pace.

- Only you perform the test.

3. Gynaecological Examination

A clinician carries out a routine pelvic exam, which may include visually checking the vulva and vaginal opening and gently assessing pelvic floor muscles to rule out other causes of pain. This ensures symptoms are due to vulvodynia and not another condition.

Modesty and comfort:

- A chaperone will be present throughout this exam.

- Only the necessary area is examined, with coverings used where possible.

- You remain in control throughout and can stop the examination at any time.

Q4: Is it safe?

Answer: Volunteer safety is always our top priority. The study medication has already been tested in earlier studies for other conditions, and participants are closely monitored throughout the trial by our expert teams. Regular health checks and open communication with the research team ensure any concerns are addressed quickly. You can also withdraw from the trial at any time and for any reason. The clinical trial has been approved by the MHRA and reviewed by an independent ethics committee.

Q5: Can I keep using my current treatments?

Answer: Some treatments may be allowed, but others might need to be paused during the study. The research team will review your medications during an initial screening visit, where your eligibility will be assessed, and we can explain what’s permitted.

Q6: Why is this trial important?

Answer: Right now, there are no licensed medications for vulvodynia in the UK. This trial could be a major step toward finding effective treatments. Even if the medication doesn’t work, the data helps scientists understand what does and doesn’t help, moving research forward. Women’s health is known to be under-researched and

under-represented, so this study is key in bridging this gap and working towards women’s health being taken more seriously.

Q7: What’s in it for participants?

Answer: If eligible, you will receive up to £1,730 for your time and commitment to the research, plus travel expenses, or MAC can arrange transport to clinic visits. MAC’s skilled medical teams will provide you with the highest standards of care and your GP will be kept informed of your participation. You’ll also receive a free health check-up, and all study-related assessments and medications will be provided free of charge. More importantly, you’ll be contributing to research that could help many women living with vulvodynia.

Q8. Will anyone know I’m taking part?

Answer: No. Your participation is confidential. Your GP is informed only so they remain updated on your medical care.

Improving Quality of Life

This research is about improving quality of life for people living with vulvodynia. Vulvodynia isn’t just pain on the vulva; it affects everyday tasks. Whether it’s pain during intimacy, discomfort sitting down, or avoiding certain clothing, it can affect mental health and relationships; vulvodynia affects so many parts of everyday

life. This study hopes to find a better way to reduce that pain and help women get back to feeling like themselves again.

If you are interested in learning more about this research and see if you qualify to take part, visit MAC’s vulvodynia research webpage.