TESTOSTERONE CIPIONATE for Paraphilic disorder | Compulsive sexual behaviour disorder

Inclusion criteria

• {"criterion_text":"- Men age 18-70 years\n- Paraphilic disorder (6D30, 6D31, 6D32, 6D33, 6D35, 6D3Z) and/or Compulsive sexual behavior disorder (6C72)\n- 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.\n- The subject has given their written consent to participate in the trial."}

Exclusion criteria

• {"criterion_text":"- Known or suspected allergies against either product\n- 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.).\n- Severe asthma ((≥2 exacerbations requiring systemic corticosteroids in the past 12 months or ≥1 hospitalization or emergency visit for asthma in the past year)\n- 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)\n- 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).\n- Previous participation in the study.\n- 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.\n- Recent or ongoing treatments that interfere with the hypothalamic–pituitary–gonadal axis or testicular function.\n- Other diseases which, according to the investigator, can affect patient safety, treatment or trial results.\n- Not suitable for inclusion by the opinion of the investigator.\n- Known or suspected breast or prostate cancer. Clinical conditions for which there are warnings and precautions to degarelix and Tostrex\n- 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.).\n- 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.\n- Clinically significant hepatic impairment and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding four times the upper limit of normal"}

Primary endpoints

• {"endpoint_text":"- Total score on the Sexual Offender Treatment Progress Scale (SOTIPS) score across the study duration measured at baseline, 30, 180 and 365 days post randomization.","definition_or_measurement_approach":"Total SOTIPS score measured at baseline, 30, 180 and 365 days post randomization across the study duration."}
• {"endpoint_text":"- Whether add-back treatment with minimal or low dose testosterone is non-inferior for risk of committing sexual abuse in the primary variable","definition_or_measurement_approach":"Assess non-inferiority of add-back minimal/low-dose testosterone versus placebo regarding the primary variable (risk of committing sexual abuse as measured in the primary endpoint)."}

Secondary endpoints

• {"endpoint_text":"- SOTIPS subscales sexual symptoms and antisocial opposition across the study duration","definition_or_measurement_approach":"SOTIPS subscale scores tracked across study duration (timing as per SOTIPS schedule)."}
• {"endpoint_text":"- SOTIPS total scores at 30 days post randomization","definition_or_measurement_approach":"SOTIPS total score measured at 30 days post randomization."}
• {"endpoint_text":"- SOTIPS total scores at 121 days post randomization","definition_or_measurement_approach":"SOTIPS total score measured at 121 days post randomization."}
• {"endpoint_text":"- SOTIPS total scores at 244 days post randomization","definition_or_measurement_approach":"SOTIPS total score measured at 244 days post randomization."}
• {"endpoint_text":"- SOTIPS total scores at 365 days post randomization","definition_or_measurement_approach":"SOTIPS total score measured at 365 days post randomization."}
• {"endpoint_text":"- The SORB/SChiMRA scores across the study duration, measured at baseline and at weekly up till day 365. Self-rated, clinician-rated and proxy-rated scores will be analyzed separately.","definition_or_measurement_approach":"SORB/SChiMRA scores measured at baseline and weekly up to day 365; analyses by rater type (self, clinician, proxy)."}
• {"endpoint_text":"- The HBI-19 total scores across the study duration, measured at baseline and at 7, 14, 60, 121, 182, 244, 304, 365 days post randomization.","definition_or_measurement_approach":"HBI-19 total score measured at baseline and at days 7, 14, 60, 121, 182, 244, 304, 365 post randomization."}
• {"endpoint_text":"- Total sexual outlet scores across the study duration, measured at baseline and at 14, 60, 121, 182, 244, 304, 365 days post randomization.","definition_or_measurement_approach":"Total sexual outlet score measured at baseline and at days 14, 60, 121, 182, 244, 304, 365 post randomization."}
• {"endpoint_text":"- Total score in the Sexual symptom assessment scale, and specific scores in the distress item across the study duration, measured at baseline, pre-treatment, 7 days, 14 days, each completed iCBT module, post-treatment, booster sessions and 365 days post randomization.","definition_or_measurement_approach":"Sexual symptom assessment total score and distress item measured at baseline, pre-treatment, days 7 and 14, each completed iCBT module, post-treatment, booster sessions and day 365."}
• {"endpoint_text":"- Total score in the screening scale for sexual interests (LASSIE) measured at baseline, end of iCBT treatment and 365 days post randomization.","definition_or_measurement_approach":"LASSIE total score measured at baseline, end of iCBT treatment, and at day 365 post randomization."}
• {"endpoint_text":"- Patient desire questionnaire (PDQ) total and subscale scores (Sexual desire, satisfaction and performance, sexual activity, mood) measured at baseline and at 14, 60, 121, 182, 244, 304, 365 days post randomization.","definition_or_measurement_approach":"PDQ total and subscale scores measured at baseline and days 14, 60, 121, 182, 244, 304, 365 post randomization."}
• {"endpoint_text":"- Change in metabolic blood biomarkers across the study period measured at baseline and at 121, 244 and 365 days post randomization.","definition_or_measurement_approach":"Metabolic blood biomarkers measured at baseline and days 121, 244 and 365; change over study period assessed."}
• {"endpoint_text":"- Change in bone mineral density and body fat composition on DXA-scan measured at baseline and 365 days post randomization.","definition_or_measurement_approach":"DXA-measured bone mineral density and body fat composition at baseline and day 365; change assessed."}
• {"endpoint_text":"- Cumulative incidence of any AEs.","definition_or_measurement_approach":"Cumulative incidence (counts/proportions) of any adverse events across study duration."}
• {"endpoint_text":"- Cumulative incidence of severe AEs","definition_or_measurement_approach":"Cumulative incidence (counts/proportions) of severe adverse events across study duration."}
• {"endpoint_text":"- Cumulative incidence of suicidal ideation requiring any type of intervention","definition_or_measurement_approach":"Cumulative incidence of suicidal ideation that required any intervention during study period."}
• {"endpoint_text":"- Time exposure to any mild, moderate and severe adverse events respectively during the trial duration.","definition_or_measurement_approach":"Time (duration) exposed to mild, moderate and severe adverse events during trial duration."}
• {"endpoint_text":"- Time exposure to each adverse event reported by >5% of participants in any of four trial arms","definition_or_measurement_approach":"Time exposure to each AE reported by >5% of participants in any arm; duration measured across trial."}
• {"endpoint_text":"- Negative effects questionnaire (NEQ) scores reported at the end of iCBT-treatment.","definition_or_measurement_approach":"NEQ scores measured at end of iCBT treatment."}
• {"endpoint_text":"- Quality of life measured with the EuroQol visual analogue scale (EQ-VAS) at baseline, each iCBT module, end of iCBT treatment and at 365 days post randomization","definition_or_measurement_approach":"EQ-VAS measured at baseline, each iCBT module, end of iCBT treatment and at day 365; QoL assessed."}
• {"endpoint_text":"- Quality and frequency of treatment experiences reported at 121, 244, 365 post randomization analysed with qualitative content analysis.","definition_or_measurement_approach":"Qualitative content analysis of treatment experience reports collected at days 121, 244 and 365 post randomization."}
• {"endpoint_text":"- SOTIPS-improvement from baseline to day 365 days post randomization","definition_or_measurement_approach":"Change in SOTIPS total score from baseline to day 365 post randomization."}
• {"endpoint_text":"- Reduction of distress-related to pedo-/pedohebephilic disorder measured with the SSAS item 10 and 11 over the study duration.","definition_or_measurement_approach":"SSAS items 10 and 11 measured over study duration to assess reduction in distress related to pedo-/pedohebephilic disorder."}
• {"endpoint_text":"- SOTIPS-improvement from baseline to 121 days post randomization.","definition_or_measurement_approach":"Change in SOTIPS total score from baseline to day 121 post randomization."}
• {"endpoint_text":"- Scores in an off-scanner sexual responsivity paradigm (such as the Viewing Time task or questionnaires such as the HBI-19)","definition_or_measurement_approach":"Off-scanner sexual responsivity scores (e.g., Viewing Time task, questionnaires such as HBI-19) measured per protocol."}
• {"endpoint_text":"- Compare treatment (degarelix versus placebo) induced neural changes, primarily in task-based bold activation but possibly also structural MRI and resting-state connectivity","definition_or_measurement_approach":"Neural changes assessed primarily via task-based BOLD activation, and possibly structural MRI and resting-state connectivity comparisons between degarelix and placebo groups."}
• {"endpoint_text":"- Use multimodal neurobiological (e.g., cortical thickness, subcortical volumes, resting-state functional connectivity, task-based BOLD activation, pupil dilation, eye-tracking, pulse fluctuations, skin-conductance data incorporation) possibly withmultimodal machine-learning methods, to delineate neurobiologically different phenotypes at baseline.","definition_or_measurement_approach":"Multimodal neurobiological measures used, possibly with machine-learning, to delineate baseline phenotypes."}
• {"endpoint_text":"- In an exploratory manner, test whether suggested disorder subtypes meaningfully predict (placebo or degarelix) treatment response over the study period.","definition_or_measurement_approach":"Exploratory predictive analyses of disorder subtypes versus treatment response over study period."}
• {"endpoint_text":"- Time to treatment discontinuation from injections","definition_or_measurement_approach":"Time-to-event analysis measuring time to discontinuation of injection treatment."}
• {"endpoint_text":"- Time to treatment discontinuation from iCBT","definition_or_measurement_approach":"Time-to-event analysis measuring time to discontinuation from iCBT."}
• {"endpoint_text":"- Number of extra visits, sessions or contacts in addition to those specified in the protocol","definition_or_measurement_approach":"Count of extra visits/sessions/contacts beyond protocol-specified visits."}
• {"endpoint_text":"- Time to rescue medication with CPA","definition_or_measurement_approach":"Time-to-event for initiation of rescue medication with CPA."}
• {"endpoint_text":"- Efficacy analyses in the primary endpoint with adjustment for CPA use.","definition_or_measurement_approach":"Primary endpoint efficacy analyses with covariate adjustment for CPA use."}
• {"endpoint_text":"- Time to rescue medication with tamoxifen","definition_or_measurement_approach":"Time-to-event for initiation of rescue medication with tamoxifen."}
• {"endpoint_text":"- SOTIPS measured across the study duration","definition_or_measurement_approach":"Repeated measures of SOTIPS across the study duration per schedule."}
• {"endpoint_text":"- SSAS scores across the study duration (pedo-/pedohebephilic disorder)","definition_or_measurement_approach":"SSAS scores tracked across the study duration for specified disorder subgroup."}
• {"endpoint_text":"- Baseline scores in the empathic concern subscale of the Brief interpersonal reactivity index (B-IRI)","definition_or_measurement_approach":"Baseline B-IRI empathic concern subscale scores collected and analyzed."}
• {"endpoint_text":"- Baseline scores in the Ritvo Autism and Asperger diagnostic scale-revised (RAADS-14)","definition_or_measurement_approach":"Baseline RAADS-14 scores collected and analyzed."}
• {"endpoint_text":"- ADHD-symptoms as reported in the MINI-neuropsychiatric interview.","definition_or_measurement_approach":"ADHD symptom presence/severity as reported in the MINI interview assessed at baseline and per protocol."}

Sweden

Earliest CTIS Part Ii Submission Date

10-04-2026

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

14

Number Of Sites

2

Number Of Participants

180

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden