Prevention of Sexual Offending with Cognitive Behavioral Therapy Alone Versus Therapy Combined with Testosterone Suppression – the PREVENT-MED randomized clinical trial
This research, called PREVENT-MED, investigates new ways to help men who experience compulsive sexual behaviours or certain sexual disorders. It compares two approaches: one group will receive a type of talking therapy called Cognitive Behavioural Therapy (CBT) on its own. The other group will receive the same CBT, but also a medication (Degarelix) that lowers testosterone levels, sometimes with a small amount of testosterone added back. We know that testosterone can influence sexual drive, so this study wants to see if lowering it, alongside therapy, is more effective at reducing sexual urges and behaviours. The study also looks at how safe these treatments are and if they have any side effects. Ultimately, it aims to find the best ways to support people in managing these conditions.
At a glance
What is this study about?
This study, called PREVENT-MED, is looking into how best to help men who have difficulties with compulsive sexual behaviours or what doctors call 'paraphilic disorders'. These conditions mean someone might have recurring intense urges, fantasies, or behaviours that cause them distress or problems in their life. The main goal is to find out if combining a special type of talking therapy, called Cognitive Behavioural Therapy (CBT), with a medication that lowers testosterone, works better than CBT alone.
Testosterone is a hormone that affects many things in the body, including sexual drive. For some people, lowering testosterone might help reduce intense sexual urges. In this study, one group of participants will receive CBT, which helps patients understand and change unhelpful thoughts and behaviours. Another group will get CBT plus a medication called Degarelix, which reduces testosterone. There will also be a group receiving a 'placebo' gel, which looks identical to a testosterone gel but has no active medication, to make sure any improvements are really due to the treatment and not just the expectation of it.
This is a 'Phase II' study, which means it’s an early stage of research. It's designed to explore if these treatments are safe and if they show promise in helping people manage their conditions. Researchers will be carefully tracking changes in sexual behaviours, urges, and overall well-being over time to see which approach is most effective. They'll also monitor any side effects from the medications.
Key takeaways
- The study explores new treatments for compulsive sexual behaviours and certain sexual disorders.
- It compares talking therapy (CBT) alone versus CBT with a testosterone-lowering drug.
- The aim is to find out which approach is most effective and safe.
- Participation involves regular appointments and assessments over about one year.
- This is an early-stage research study (Phase II).
Who may be eligible?
To be considered for this study, you must be male and at least 18 years old. The study is specifically for men who have been diagnosed with certain sexual disorders or compulsive sexual behaviour disorders.
It's important that you understand what the study involves and are willing to take part in all aspects of it. You'll need to be available for regular check-ups and assessments over a period of time.
- Are you male?
- Are you 18 years old or older?
- Have you been diagnosed with a compulsive sexual behaviour disorder or a paraphilic disorder?
- Are you willing and able to attend regular appointments for about a year?
- Are you able to provide informed consent to participate?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would be involved for about a year. You would have regular appointments, starting with a baseline visit to gather initial information. After that, you'd have follow-up visits after 30 days, 180 days, and a final visit at 365 days. During these visits, researchers will assess your sexual behaviours and urges using special questionnaires and tools. You might also have blood tests and other scans to check your general health and see if the treatment is having any impact on your body.
Depending on which treatment group you are in, you would either receive a talking therapy called Cognitive Behavioural Therapy (CBT) on its own, or CBT combined with a medication called Degarelix, which lowers testosterone. If you receive medication, you might also be given a small amount of testosterone back to help manage any potential side effects. The study involves taking medication or using a gel, and attending therapy sessions as scheduled. All treatments and assessments will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is Cognitive Behavioural Therapy (CBT)?
CBT is a type of talking therapy that helps you understand how your thoughts and feelings affect your behaviour, and gives you tools to change unhelpful patterns.
What is Degarelix?
Degarelix is a medication that lowers the amount of testosterone in your body. Testosterone is a hormone that can affect sexual urges.
Will I know which treatment I am getting?
This is a 'randomised' study, meaning you will be assigned to a treatment group by chance. Sometimes, in these types of studies, neither you nor the doctors know which treatment you are receiving (this is called 'blinding').
How long will the study last if I join?
If you participate, the study will involve treatments and check-ups over a period of up to 365 days, or roughly one year.
What does 'paraphilic disorder' mean?
It's a medical term for intense, recurring sexual urges, fantasies, or behaviours that cause distress or significant problems in a person's life.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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