Trial intelligence / Profile preview

TestICUs: Testosterone Gel in Critically Ill Patients

NCT05825092Phase 2

Key facts

Status: Recruiting
Start: Jul 2023
Primary completion: Sep 2025
Countries: 1
Sponsor: Centre Hospitalier Universitaire de Clermont-Ferrand
Modality: Small Molecules

Drugs: AndroForte
Conditions: critical illness

Overview

Phase 2, randomised, double-blind trial in critical illness comparing AndroGel 1.62% with Placebo (2 arms). Primary endpoint: 6-minute-walk distance at 3 months. Started Jul 2023; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

AndroGel 1.62%
Daily application of testosterone gel
Placebo
Daily application of placebo gel

Who it enrols

Critically ill patients aged 18-80 requiring invasive mechanical ventilation for >48 hours. Excludes patients with history of prostate or breast cancer, PSA >= 4 ng/ml, recent stroke/CNS injury, neuromuscular disease, or inability to walk prior to illness.

Endpoints

Primary

6-minute-walk distance3 months

Secondary

6-minute-walk distance1 year
Activities of Daily Living and Instrumental Activities of Daily Living1 year
Oxygen muscular consumption with NIRS3 months
Mid-arm muscle circumference1 year
Short Physical Performance Battery1 year
Medical Outcomes Study 36 Item Short Form Health Survey Physical Component1 year
Muscle strength by Handgrip test1 year
Medical Research Council score1 year

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