Trial intelligence / Profile preview

Naltrexone for hypersexual disorder: open-label pilot feasibility study

2018-001049-15Phase 2

Key facts

Status
Completed
Start
Jun 2018
Countries
1
Modality
Small Molecules
Conditions
hypersexuality
01

Overview

Phase 2, open-label, single-arm trial of naltrexone in hypersexuality, sponsored by Anova Evidence. Primary endpoint: Feasibility (primary). Started Jun 2018; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Naltrexone monotherapy

    All enrolled participants receive open-label naltrexone for treatment of hypersexual disorder.

03

Who it enrols

Adults with a diagnosis of hypersexual disorder; patients with liver enzymes (ALAT or ASAT) greater than three times the upper limit of normal are excluded.

04

Endpoints

Primary

  • Feasibility (primary)

Secondary

  • Efficacy (exploratory)

  • Tolerability (exploratory)

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