Hypersexual disorder MedDRA version: 20.0 Level: PT Classification code 10066364 Term: Hypersexuality System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Naltrexon Vitaflo
Pharmaceutical Form: Coated tablet
Sponsors
ANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A diagnosis of hypersexual disorder (as described in the protocol). • 18- 65 years old • Signed informed consent • Able to understand the Swedish language orally and in written, write in Swedish and able to use the internet including having succeeded in filling out online questionnaires. • Willing to participate to all study visits including giving blood and urine samples. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Elevated liver enzymes (greater than three times the upper limit of normal for ALAT and/or ASAT). • Ongoing opioid or benzodiazepine medication. • Illicit self-reported use of drugs in the past month or positive drug verification analysis. • Risk consumption of alcohol in the past month or alcohol dependence (14 units of alcohol per week for men and 9 units per week for women will be considered risk consumption). • Severe psychiatric disorder such as current psychotic illness or severe depression requiring immediate treatment. • History of liver or kidney failure. • Serious physical illness. • Change of medication or dosage in the last 3 months regarding antidepressants, ADHD-medication, mood stabilizers, anti-psychotics, cortisone, testosterone or precursor of Dopamine such as L-Dopa. • Pregnancy and/or breast-feeding. • Ongoing psycho-therapeutic treatment. • History of allergic reaction to Naltrexone or its metabolites. • Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or psychologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this pilot study is to assess feasibility, efficacy and tolerability of Naltrexone treatment in patients with hypersexual disorder. The following research questions will be asked: 1. Is treatment with Naltrexone feasible for patients with Hypersexual disorder treated at a sub specialized unit? 2. Does Naltrexone reduce symptoms in patients with Hypersexual disorder? And if so, what clinical characteristics predict response? 3. What is the tolerability of Naltrexone in patients with Hypersexual disorder?;Secondary Objective: Not Applicable;Primary end point(s): 1. Feasibility: Assessed continually as the research group evaluate the procedures and receive input from patients. 2. Effect: self- assessment HD: CAS 3. Tolerability: - Treatment drop out - Self-reported adherence to treatment - Discontinuation/ exclusion from study due to serious adverse effects or elevated liver tests - Reported adverse effects. ;Timepoint(s) of evaluation of this end point: Endpoint 1: continuously throughout the study Endpoint 2: week 8 (End of Study) Endpoint 3: week 8 (End of Study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Feasibility: None 2. Effect: - HBI assessment - Compare outcome in patients with different clinical characteristics; captured in internet-based questionnaires and at the clinical evaluation 3. Tolerability: None;Timepoint(s) of evaluation of this end point: Week 8 (End of Trial) | — |
Countries
Sweden
Contacts
Public ContactJosephine Savard
ANOVA (Andrologi, Sexualmedicin, Transmedicin)
Outcome results
None listed