Table 2

Study assessments

ObjectiveAssessmentsMeasure typeTime point
Assess changes in compulsive sexual behaviours from screening to week 8 and follow-upHypersexual Disorder: Current Assessment Scale (HD: CAS)OutcomeBaseline, weeks 2, 4, 6, 8 and end of study
Assess compulsive sexual behavioursThe Hypersexual Disorder Screening Inventory (HDSI)EligibilityBaseline, and end of study
Assess changes in compulsive sexual behaviours from screening to week 8 and follow-upThe Hypersexual Behaviour Inventory (HBI)OutcomeBaseline, weeks 1–4, week 6, week 8 and end of study
Assess changes in compulsive sexual behaviours from screening to week 8 and follow-upSexual Compulsivity Scale (SCS)OutcomeBaseline, weeks 1–4, week 6, week 8 and end of study
Assess sexual interestsSelf-assessment of sexual interests (SSI)EligibilityBaseline
Assess sexual dysfunctionInternational Index of Erectile Function (IIEF)*EligibilityBaseline
Assess psychiatric comorbidityMini-International Neuropsychiatric Interview (MINI)EligibilityBaseline
Assess changes in depression severity from screening to week 8 and follow-upMontgomery 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-upHospital Anxiety and Depression Scale (HAD)OutcomeBaseline, week 8 and end of study
Assess changes in alcohol use from screening to week 8 and follow-upAlcohol Use Disorders Identification Test (AUDIT)OutcomeBaseline, week 8 and end of study
Assess use of drugsDrug Use Disorders Identification Test (DUDIT)EligibilityBaseline
Assess pathological gamblingGambling Disorder Identification Test (G-DIT)EligibilityBaseline
Assess impulsivityBarratt Impulsiveness Scale (BIS-11)EligibilityBaseline
Assess symptoms of attention-deficit/ hyperactivity disorderAdult ADHD Self-Report Scale (ASRS)EligibilityBaseline
Assess history of violenceKarolinska Interpersonal Violence Scale (KIVS)EligibilityBaseline
Assess history of childhood traumaThe Childhood Trauma Questionnaire—Short Form (CTQ-SF)EligibilityBaseline
Assess suicide ideation and suicidal behaviour throughout the studyColumbia Suicide Severity Rating Scale (C-SSRS)SafetyBaseline, weeks 1, 4, 8 and end of study
Assess adverse reactions in week 8Udvalg for Kliniske Undersogelser side effect rating scale (UKU)TolerabilityWeek 8
Question of wanting to resume pharmacological treatment, week 14Yes/no/do not know optionOutcomeEnd of study
  • *Assigned men at birth only.