PREVENT-MED Prevention of Sexual Offending through Testosterone Suppression and Medical Exploration of Side Effect Mitigation

Purpose and aims: This application is a means to plan and launch a multicenter randomized controlled trial (RCT).

The objective of the RCT is to assess the long-term (12 months) efficacy and safety of degarelix (D), a gonadotropin-releasing hormone antagonist, combined with hormonal add-back therapy + treatment as usual (TAU; diagnostic assessment and psychotherapy) compared with TAU only, for reducing the risk of committing sexual abuse in patients posing a threat to others.

Background: We have previously reviewed the evidence in the field.

The evidence from RCTs is limited, with psychotherapy and testosterone-lowering drugs in severe cases being commonly used approaches.

Planning: Building on the evidence and experience from our two previous placebo-controlled short-term RCTs, we plan a multistage, long-term RCT-design with three stages and randomizations over 12 months.

The objective of the trial is to measure efficacy in reducing risk for committing sexual abuse and evaluate strategies for side-effect mitigation.

With funds from this planning grant we will be able to complete i) necessary applications, protocols, ii) procurement of study drugs, and iii) establishment and coordination of the infrastructure needed for multicenter recruitment in additional regions.

Conclusion: Execution of this RCT will provide evidence readily translatable for clinical application in a medical field dearth of services and treatments.