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Prevention of Sexual Offending with Cognitive Behavioral Therapy Alone Versus Therapy Combined with Testosterone Suppression – the PREVENT-MED randomized clinical trial
EU CTIS ID: 2024-518120-68-01
What this study is testing
Assess the effectiveness of CBT + degarelix in reducing risk for committing sexual abuse and related behaviours in participants with psychiatric sexual disorders in comparison with CBT and placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men age 18-70 years
- Paraphilic disorder (6D30, 6D31, 6D32, 6D33, 6D35, 6D3Z) and/or Compulsive sexual behavior disorder (6C72)
- Increased risk of comitting a sexual offense based on one or more of the following: I – previous conviction of sexual offense II – high risk reflected in risk rating scales (SORB/SChiMRA -A or-B >4 (range 0-10) SChiMRA+ (Part A and B): A score >4 on item #2 or #3 in SChiMRA-A, and/or at least 1 day on item #2 or #3 in SChiMRA-B. III – Investigator-rated high risk for commission of sexual offense.
- The subject has given their written consent to participate in the trial.
You likely can't join if
- Known or suspected allergies against either product
- Clinically significant renal impairment and/or an estimated glomerual filtration rate <30 mL/min/1,73 m² at screening based on the revised Lund-Malmö equation (‘Njurfunktion’, n.d.).
- Severe asthma ((≥2 exacerbations requiring systemic corticosteroids in the past 12 months or ≥1 hospitalization or emergency visit for asthma in the past year)
- Presence of one or more major cardiovascular or metabolic risk factors, including any of the following: - known atherosclerotic disease (heart, brain, or peripheral arteries), - uncontrolled hypertension (repeated blood pressure measurements >180/110 mmHg) - type 1 or type 2 diabetes mellitus - familial hypercholesterolemia - parental history of premature myocardial or cerebral infarction (before 50 years of age)
- Ongoing severe substance use disorder (Meets diagnostic criteria for Substance use disorder according to ICD-11 and either i] active use of illicit drugs or non-prescribed controlled substances within the past 90 days, or ii] positive urine drug screen at screening or baseline unless explained by prescribed medication).
- Previous participation in the study.
See the full eligibility criteria
Who can join
- Men age 18-70 years
- Paraphilic disorder (6D30, 6D31, 6D32, 6D33, 6D35, 6D3Z) and/or Compulsive sexual behavior disorder (6C72)
- Increased risk of comitting a sexual offense based on one or more of the following: I – previous conviction of sexual offense II – high risk reflected in risk rating scales (SORB/SChiMRA -A or-B >4 (range 0-10) SChiMRA+ (Part A and B): A score >4 on item #2 or #3 in SChiMRA-A, and/or at least 1 day on item #2 or #3 in SChiMRA-B. III – Investigator-rated high risk for commission of sexual offense.
- The subject has given their written consent to participate in the trial.
What rules you out
- Known or suspected allergies against either product
- Clinically significant renal impairment and/or an estimated glomerual filtration rate <30 mL/min/1,73 m² at screening based on the revised Lund-Malmö equation (‘Njurfunktion’, n.d.).
- Severe asthma ((≥2 exacerbations requiring systemic corticosteroids in the past 12 months or ≥1 hospitalization or emergency visit for asthma in the past year)
- Presence of one or more major cardiovascular or metabolic risk factors, including any of the following: - known atherosclerotic disease (heart, brain, or peripheral arteries), - uncontrolled hypertension (repeated blood pressure measurements >180/110 mmHg) - type 1 or type 2 diabetes mellitus - familial hypercholesterolemia - parental history of premature myocardial or cerebral infarction (before 50 years of age)
- Ongoing severe substance use disorder (Meets diagnostic criteria for Substance use disorder according to ICD-11 and either i] active use of illicit drugs or non-prescribed controlled substances within the past 90 days, or ii] positive urine drug screen at screening or baseline unless explained by prescribed medication).
- Previous participation in the study.
- Participants with mental inability, reluctance, or language difficulties that result in difficulty understanding the meaning of participation in the trial, or who are unable to speak, read, and understand Swedish or English, and respond to questions, follow instructions, complete questionnaires, and follow the study procedure, will be excluded.
- Recent or ongoing treatments that interfere with the hypothalamic–pituitary–gonadal axis or testicular function.
- Other diseases which, according to the investigator, can affect patient safety, treatment or trial results.
- Not suitable for inclusion by the opinion of the investigator.
- Known or suspected breast or prostate cancer. Clinical conditions for which there are warnings and precautions to degarelix and Tostrex
- Diagnosed osteoporosis, or a 10-year probability of major osteoporotic fracture (MOF) is ≥15% or 10-year probability of hip fracture is ≥5% according to Fracture Risk Assessment Tool (FRAX)(‘FRAX’, n.d.).
- Clinically significant QT-c-prolongation >450 milliseconds Major or uncontrolled liver or kidney disease, severe asthma, or ongoing severe substance use disorder), and where the clinical risk/benefit assessment concludes a significant risk to the patient's well-being.
- Clinically significant hepatic impairment and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding four times the upper limit of normal
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.