A study to see if fluoxetine will help reduce the symptoms of problematic sexual arousal in adult men serving a prison sentence when compared with a placebo (dummy) drug
Problematic sexual arousal happens when a person experiences intense, frequent sexual thoughts and urges that feel out of control and cause serious distress. Currently, treatments can cause unwanted side effects or are not widely available. This trial is looking at whether fluoxetine, a common medicine usually used for low mood, can help. Fluoxetine is known to gently lower sexual drive in many people. Men in participating prisons who have been referred to a specialist service will take either fluoxetine or a dummy pill (placebo) once a day for six months. Neither the men nor their prison doctors will know who is taking which pill. Researchers will track changes in urges and any side effects. The goal is to see if fluoxetine is a safe, helpful treatment that the NHS could recommend for people in prison and the wider community.
At a glance
What is this study about?
Problematic sexual arousal is a condition where sexual thoughts, feelings, and urges become overwhelming and very difficult to manage. For men in prison, these distressing symptoms can have a significant impact on everyday life, mental health, and personal relationships. Finding safe, practical treatments to help people regain a sense of control is an important part of healthcare in these settings.
At present, some treatments for strong sexual urges involve medications that lower male hormone levels. While these can work, they often come with difficult side effects. Fluoxetine is a well-known tablet that belongs to a family of medicines called SSRIs. Doctors have noticed that one of its common effects is reducing sexual urges. Smaller studies suggest it could be a helpful, gentler, and lower-cost option for people struggling with unwanted sexual arousal.
This Phase III study aims to gather clear evidence on whether fluoxetine truly works better than a dummy pill. If the findings show that fluoxetine safely reduces distress and provides good value for the NHS, it could help update national healthcare guidelines. This would make it easier for doctors to prescribe the medicine to men managing these symptoms, both in prison and after their release into the community.
Key takeaways
- Tests whether fluoxetine helps men in prison manage distressing sexual urges.
- Compares the active medicine against a dummy pill (placebo) over six months.
- Open to adult men referred to the prison's specialist sexual arousal service.
- Involves filling in a daily symptom diary and three health questionnaires.
- Completely voluntary, with no effect on prison sentence, release, or legal rights.
Who may be eligible?
This study is open to adult men aged 18 and older who are currently living in a participating prison and have been referred to the specialist Medication to Manage Problematic Sexual Arousal (MMPSA) service. Participants must have a formal diagnosis of problematic sexual arousal from a specialist doctor, be able to understand the study in English, and agree to use reliable contraception during the trial and for six months after finishing.
Men cannot take part if they are already taking certain medicines that affect brain chemicals or hormones, or if they have medical conditions such as epilepsy. They also cannot take part if they are currently experiencing severe, acute mental illness that stops them giving informed consent, or if being placed on a dummy pill would put them or others at high risk.
In addition, participants must have enough time left on their sentence. Anyone who is due to be released or moved to another prison without this specialist service within the next nine months will not be able to join.
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.
- I am a man aged 18 or over in a prison running the study.
- I have been referred to the MMPSA service for distressing sexual urges.
- I am not currently taking antidepressants or hormone-blocking medicines.
- I do not have epilepsy or medical reasons preventing me from taking fluoxetine.
- I have at least nine months remaining before any release or prison transfer.
What does participation involve?
Taking part in the study lasts for six months. At the start, a computer will randomly place each participant into one of two groups: one group takes a daily fluoxetine capsule, and the other takes a matching dummy capsule (placebo) that contains no active medicine. Neither the participant nor the prison healthcare team will know which capsule has been assigned.
Participants will take their pill each day and complete a quick daily diary to record any side effects, changes to other medicines, or visits to healthcare staff. Specialist researchers will also ask participants to fill out short questionnaires at the start of the study, at three months, and at six months to check how they are feeling. Once the six months are complete, the prison doctor will find out which tablet the participant took and will discuss the best next steps for their ongoing care.
Potential risks and benefits
Locations (1)
- The trial will take place in several prisons in England and Wales.City only-, England
Common questions
What is a placebo?
A placebo is a dummy pill that looks, smells, and tastes just like the real medicine, but contains no active ingredients. It helps researchers see if changes are truly caused by the drug.
Will taking part affect my prison sentence or parole?
No. Taking part in medical research is completely confidential and has no impact on your sentence, parole decisions, or release date.
Can I pick whether I get fluoxetine or the dummy pill?
No. A computer randomly decides which pill you receive so that the study results remain fair and unbiased.
What happens if I feel unwell while taking the study medicine?
You will be closely looked after by prison healthcare staff. You can report any side effects in your daily diary or speak directly to a nurse or doctor at any time.
What happens after the six months are over?
Your doctor will find out which pill you received and work with you to plan your regular ongoing treatment as part of standard NHS care.
How to find out more
Richard Emes
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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