Effects of testosterone gel on physical performance in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of early administration of testosterone gel on physical performance in critically ill patients who are expected to require invasive mechanical ventilation for more than 48 hours. The study aims to address the severe testosterone deficiency commonly observed in these patients, which may contribute to muscle loss and functional disability. By comparing the effects of testosterone gel to a placebo, the trial seeks to determine whether testosterone can improve muscle strength and recovery during critical illness. The approach involves monitoring physical performance and muscular mass as primary outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females aged over 18 years
* Negative pregnancy test (b-HCG) in female patient of childbearing potential
* Invasive mechanical ventilation expected to be required for more than 48 hours
* Written informed consent obtained from the patient or his/her legal representative
* Social security cover
* Contraception
* Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 7 months after the last treatment intake
* Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 4 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 4 months after the last treatment intake

Exclusion Criteria:

* History of prostate cancer
* History of breast cancer
* Prostate cancer suspected or confirmed
* Breast cancer suspected or confirmed
* PSA (prostatic specific antigen) ≥ 4 ng/ml
* ICU length of stay \> 120 h before enrollment
* Moribund
* Pre-existing illness with a life expectancy of \<6 months
* Recent intracranial or spinal cord injury (\< 1 month)
* Recent haemorrhagic or ischemic stroke (\< 1 month)
* Neuromuscular disease
* Cardiac arrest in non-shockable rhythm
* Preexistent cognitive impairment or language barrier
* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not excluded)
* Documented allergy to testosterone
* Age \> 80 years
* Pregnancy
* Breast feeding

Where it's running

• Service d'Anesthésie et Réanimation Centre Jean-Perrin
  Clermont-Ferrand, France Recruiting
• Service de Médecine Intensive et Réanimation (MIR), CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Service de Médecine Intensive et de Réanimation CHD La Roche sur Yon
  La Roche-sur-Yon, France Recruiting
• Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux
  Nantes, France Recruiting
• Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin
  Bordeaux, France Not yet recruiting

Study contacts

• Principal investigator: Konstantinos BACHOUMAS, MD — Centre Hospitalier Departemental Vendee
• Study coordinator: Lise LACLAUTRE
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.