A single dose of the prostate cancer drug degarelix statistically significantly reduced the risk of committing child sexual abuse in help-seeking men with pedophilic disorder 2 weeks after the initial injection, according to a study published in JAMA Psychiatry.
“Degarelix acetate is a gonadotropin-releasing hormone antagonist that was approved by the US Food and Drug Administration in 2008 for treating advanced prostate cancer,” researchers wrote. “Degarelix decreases testosterone to castration levels within 3 days without testosterone flare; therefore, the drug could serve as a rapid-onset treatment for individuals seeking help in outpatient settings.”
The double-blind, phase 2 clinical trial included 52 men with a diagnosis of pedophilic disorder who contacted a Swedish phone helpline for unwanted sexuality. Participants were randomized to two subcutaneous injections of 120 mg of either degarelix acetate or placebo. Researchers were primarily interested in the average change between baseline and 2 weeks in the composite risk score of five domains of child sexual abuse. Each domain could be rated from 0 to 3 points, for a total risk score of 0 to 15.
At 2 weeks, the composite risk score decreased from 7.4 to 4.4 for men in the degarelix group and from 7.8 to 6.6 for the placebo group, for an average between-group difference of –1.8, researchers reported. By 10 weeks, the between-group difference grew to −2.2.
“The rapid onset of degarelix appears to have a crucial advantage compared with earlier medications for paraphilic disorders, which had a 1 to 3 months’ lag in exerting their effects on sexuality,” researchers wrote.
In the degarelix group compared with the placebo group, decreases were also demonstrated in the domains of pedophilic disorder and sexual preoccupation at both 2 weeks and 10 weeks after initial injection. However, no differences were found for the domains of self-rated risk, low empathy, and impaired self-regulation, or in quality of life.
A serious adverse event of increased suicidal ideation leading to hospitalization was reported by 2 of 25 men in the degarelix group. In addition, 88% of men who received degarelix reported injection site reactions, and 44% of men in the degarelix group reported hepatobiliary enzyme level elevations.
“In weighing the benefits and harms of the drug, we found that the participants self-reported a more positive than negative attitude toward treatment, specifically regarding the effects on sexuality,” researchers wrote. “Thus, participants expressed relief of symptoms for which they sought help, in addition to experiencing the treatment aim of risk reduction.”
Landgren V, Malki K, Bottai M, Arver S, Rahm C. Effect of gonadotropin-releasing hormone antagonist on risk of committing child sexual abuse in men with pedophilic disorder: a randomized clinical trial. JAMA Psychiatry. 2020 April 29;[Epub ahead of print].