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Comparing cognitive behavioral therapy alone versus cognitive behavioral therapy combined with degarelix to prevent sexual offenses in patients with paraphilic disorders

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to assess the effectiveness of combining Cognitive Behavioral Therapy, a type of talk therapy that helps people change unhelpful thoughts and behaviors, with medication to reduce the risk of sexual offenses in individuals with Paraphilic disorder or Compulsive sexual behavior disorder. Participants may receive degarelix, a medication used to suppress hormone levels, alongside the therapy. In some cases, testosterone cipionate, a form of testosterone, may be provided through a gel applied to the skin to manage certain effects of the suppression medication.

The study compares different treatment approaches. Some participants will receive only the talk therapy, while others will receive the therapy combined with degarelix or a placebo. This research looks at how these different combinations affect behaviors and symptoms over time. Participants will be monitored for a period of time to observe changes in their behavior and physical health.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in therapy

    You will participate in cognitive behavioral therapy, which is a type of talk therapy designed to help change certain patterns of thinking and behavior.

    This therapy may be delivered through internet-based modules.

  2. Step 2

    Medication administration

    You will be assigned to one of two groups. one group receives a subcutaneous injection, which is an injection administered just under the skin, of degarelix at a dose of 2.63 mg to suppress testosterone levels. the other group receives a placebo injection, which is an injection containing no active medicine, consisting of 0.07 ml of a solution.

    Depending on your assigned group, you may also receive testosterone to manage side effects. this is administered as a 20 mg dose of testosterone cipionate via cutaneous use, which means it is applied to the skin as a gel.

    The group receiving the placebo injection instead receives a placebo gel that is identical to the testosterone gel.

  3. Step 3

    Monitoring and assessments

    You will undergo various assessments to track progress. these include scales to measure sexual symptoms, antisocial opposition, and sexual desire.

    Regularly scheduled assessments will occur at specific intervals, such as 7, 14, 30, 60, 121, 182, 244, 304, and 365 days after the start of the study.

    Medical tests will be conducted to monitor changes, including blood tests to check metabolic biomarkers at 121, 244, and 365 days.

    Physical measurements will be taken at the beginning and at 365 days, including a DXA-scan to measure bone mineral density (bone strength) and body fat composition.

Who can join the trial?

4 criteria

  • Participants must be men between the ages of 18 and 70 years.
  • Participants must have a paraphilic disorder, which is a condition involving intense and persistent sexual interests that are unusual or may cause distress, or compulsive sexual behavior disorder, which involves difficulty controlling sexual urges.
  • Participants must show an increased risk of committing a sexual offense through one of these ways: having a previous conviction (a legal judgment that someone is guilty of a crime), having a high score on risk rating scales (specialized tools used by professionals to measure how likely someone is to repeat an offense), or being judged as high risk by the study researcher.
  • Participants must provide written consent, which means they must sign a document showing they agree to take part in the study.

Who cannot join the trial?

17 criteria

  • You have a known or suspected allergy, which is an immune system reaction, to any of the study medications.
  • You have significant kidney impairment, meaning your kidneys are not working properly, or your estimated glomerular filtration rate (a measure of how well your kidneys filter blood) is too low.
  • You have severe asthma, defined as having had multiple flare-ups requiring steroid treatment or hospital visits in the last year.
  • You have major cardiovascular risk factors, which are conditions that increase the chance of heart disease or stroke, such as atherosclerotic disease (hardened or blocked arteries), uncontrolled hypertension (high blood pressure), type 1 or type 2 diabetes, or familial hypercholesterolemia (a genetic condition causing high cholesterol).
  • You have a family history of premature myocardial or cerebral infarction, which means a parent had a heart attack or stroke before age 50.
  • You have an ongoing substance use disorder, which is a medical condition involving the harmful use of drugs or alcohol, including the recent use of illegal drugs.
  • You have previously participated in this specific study.
  • You have mental inability, reluctance, or language difficulties that make it hard to understand the study, follow instructions, or communicate in Swedish or English.
  • You are currently receiving treatments that affect the hypothalamic-pituitary-gonadal axis (the system of glands that controls hormones) or testicular function.
  • You have any other health conditions that, in the doctor's opinion, could make participation unsafe or affect the study results.
  • The investigator (the main doctor in charge of the study) decides you are not suitable for the trial.
  • You have a known or suspected history of breast or prostate cancer.
  • You have conditions that require special warnings when using the study medications.
  • You have osteoporosis (weak or brittle bones) or a high calculated risk of breaking a bone in the next 10 years based on a tool called FRAX.
  • You have QT-c prolongation, which is a specific change in the electrical activity of your heart rhythm that lasts longer than normal.
  • You have major or uncontrolled liver disease or kidney disease that puts your health at risk.
  • You have significant hepatic impairment, meaning your liver is not functioning correctly, or your ALT or AST levels (enzymes measured in blood tests that indicate liver health) are much higher than normal.
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Investigated drugs

  • Testosterone

    is a hormone used in this study to study its effects on sexual behaviors. It is applied through the skin.

  • Degarelix

    is a medication used to lower the levels of testosterone in the body. It is given as an injection under the skin.

What is already known about the treatment

  • Testosterone cipionate

    This medication is an androgen hormone applied through the skin to be absorbed into the body. It is an established treatment used primarily to replace low testosterone levels in men. At a molecular level, it works by binding to androgen receptors, which helps regulate various bodily functions and sexual characteristics. It is pharmacologically classified as an androgen replacement therapy.

  • Degarelix

    This medication is administered as a shot injected just under the skin. It is an approved drug used mainly to treat advanced prostate cancer by lowering hormone levels. It works by directly blocking the receptors in the body that signal the production of hormones, effectively shutting down the hormone supply at its source. It is pharmacologically classified as a gonadotropin-releasing hormone antagonist.

Investigated diseases

Compulsive sexual behavior disorder - This condition involves a persistent pattern of failure to control intense, repetitive sexual impulses or urges. These urges may lead to sexual activities that cause significant distress or interfere with a person's daily responsibilities and relationships. The behavior often becomes increasingly difficult to resist over time. It can involve an obsession with sexual thoughts or an inability to limit sexual activities. The condition typically progresses as the individual relies on these behaviors to cope with various emotions or stressors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518120-68-01Protocol codePREVENT-MEDEstimated enrolment180 patientsSponsorVaestra Goetalandsregionen

sourced from the EU Clinical Trials Register and site verification

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