Table 2.
Study assessments
| Objective | Assessments | Measure type | Time point |
| Assess changes in compulsive sexual behaviours from screening to week 8 and follow-up | Hypersexual Disorder: Current Assessment Scale (HD: CAS) | Outcome | Baseline, weeks 2, 4, 6, 8 and end of study |
| Assess compulsive sexual behaviours | The Hypersexual Disorder Screening Inventory (HDSI) | Eligibility | Baseline, and end of study |
| Assess changes in compulsive sexual behaviours from screening to week 8 and follow-up | The Hypersexual Behaviour Inventory (HBI) | Outcome | Baseline, weeks 1–4, week 6, week 8 and end of study |
| Assess changes in compulsive sexual behaviours from screening to week 8 and follow-up | Sexual Compulsivity Scale (SCS) | Outcome | Baseline, weeks 1–4, week 6, week 8 and end of study |
| Assess sexual interests | Self-assessment of sexual interests (SSI) | Eligibility | Baseline |
| Assess sexual dysfunction | International Index of Erectile Function (IIEF)* | Eligibility | Baseline |
| Assess psychiatric comorbidity | Mini-International Neuropsychiatric Interview (MINI) | Eligibility | Baseline |
| Assess changes in depression severity from screening to week 8 and follow-up | Montgomery Åsberg Depression Rating Scale—self-rating (MADRS-S) | Outcome safety |
Baseline, week 8 and end of study |
| Assess change of symptoms of depression and anxiety from screening to week 8 and follow-up | Hospital Anxiety and Depression Scale (HAD) | Outcome | Baseline, week 8 and end of study |
| Assess changes in alcohol use from screening to week 8 and follow-up | Alcohol Use Disorders Identification Test (AUDIT) | Outcome | Baseline, week 8 and end of study |
| Assess use of drugs | Drug Use Disorders Identification Test (DUDIT) | Eligibility | Baseline |
| Assess pathological gambling | Gambling Disorder Identification Test (G-DIT) | Eligibility | Baseline |
| Assess impulsivity | Barratt Impulsiveness Scale (BIS-11) | Eligibility | Baseline |
| Assess symptoms of attention-deficit/ hyperactivity disorder | Adult ADHD Self-Report Scale (ASRS) | Eligibility | Baseline |
| Assess history of violence | Karolinska Interpersonal Violence Scale (KIVS) | Eligibility | Baseline |
| Assess history of childhood trauma | The Childhood Trauma Questionnaire—Short Form (CTQ-SF) | Eligibility | Baseline |
| Assess suicide ideation and suicidal behaviour throughout the study | Columbia Suicide Severity Rating Scale (C-SSRS) | Safety | Baseline, weeks 1, 4, 8 and end of study |
| Assess adverse reactions in week 8 | Udvalg for Kliniske Undersogelser side effect rating scale (UKU) | Tolerability | Week 8 |
| Question of wanting to resume pharmacological treatment, week 14 | Yes/no/do not know option | Outcome | End of study |
*Assigned men at birth only.