A medical treatment trial investigating whether degarelix decreases the risk of persons with pedophilic disorder from committing sexual child molestation

Investigation of the efficacy of degarelix as an acute treatment for patients with pedophilic disorder to reduce the risk for sexual child molestation: a prospective, randomized, double blind, and placebo controlled study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000647-32-SE

Enrollment

Registered

2014-04-08

Start date

2014-10-22

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pedophilia acccording to DSM-5 (F65.4)

Interventions

Trade Name: FIRMAGON Pharmaceutical Form: Powder and solution for solution for injection CAS Number: 214766-78-6 Other descriptive name: DEGARELIX Concentration unit: mg/ml milligram(s)/millilitre Con

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male >= 18 -65 years Diagnos pedophilia 302.2 according to DSM-5 Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diagnose of osteporosis Extended QT/QTc ration on ECG (>450 ms) Symptoms or riskfactors known to increase the risk for QT extension (e.g. a history or (family heridity) of cardiac events that indicate a prolongation of QT interval e.g. freqent attacs of syncopé, or propensity to ventricular tachyarrhythmias). On current medical treatment with pharmaceutical substances that could increase QT interval. Known liver disease/function Known kidney disease/function Severe asthma Known allery to IMP and/or IMP excipients Ongoing drugabuse, measured in AUDIT/DUDIT Any indications that MRI measurement are contraindiciated (i.e. metal clips brain etc.) Any other condition that could jepordize the trial scientificly or patients health, as judged by the investigator Particiaption in another clincial trial

Design outcomes

Primary

Measure	Time frame
Main Objective: Do degarelix reduce the risk of committing sexual child molestation for patients with pedophilic disorder? ;Secondary Objective: How safe is the substance to use? Does riskfactors correlate with biomarkers (under given dose)? ;Primary end point(s): Primary endpoint consists of a composite measure of 0-15 points, based on estimates for different risk factors for sexual abuse. 0-5 = low risk. 6-10 = medium risk. 11-15 = high risk. Primary endpoint mirrors therefore risk the abuse of children, it is not the actual number of sexual abuse of children.;Timepoint(s) of evaluation of this end point: 2 weeks after dosing	—

Measure

Time frame

Main Objective: Do degarelix reduce the risk of committing sexual child molestation for patients with pedophilic disorder? ;Secondary Objective: How safe is the substance to use? Does riskfactors correlate with biomarkers (under given dose)? ;Primary end point(s): Primary endpoint consists of a composite measure of 0-15 points, based on estimates for different risk factors for sexual abuse. 0-5 = low risk. 6-10 = medium risk. 11-15 = high risk. Primary endpoint mirrors therefore risk the abuse of children, it is not the actual number of sexual abuse of children.;Timepoint(s) of evaluation of this end point: 2 weeks after dosing

—

Secondary

Measure	Time frame
Secondary end point(s): Adveres events biomarkers ;Timepoint(s) of evaluation of this end point: 0-100 days after treatment	—

Countries

Sweden

Contacts

Public ContactStefan Arver

Karolinska University Hospital

stefan.arver@ki.se+46858582376

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026