Effects of testosterone gel on physical performance in critically ill patients
Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial
This study tests if giving testosterone gel to critically ill patients on a ventilator can help improve their muscle strength and recovery compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT05825092 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females over 18 years old who are critically ill and require invasive mechanical ventilation for an extended period.
Not a fit: Patients who are not critically ill or those who do not require mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance muscle recovery and physical performance in critically ill patients, potentially improving their overall outcomes.
How similar studies have performed: While the specific approach of using testosterone gel in critically ill patients is novel, previous studies have indicated that addressing hormonal deficiencies can have positive effects on recovery in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 4 other locations
- Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin — Bordeaux, France (Not_yet_recruiting)
- 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)
Study contacts
- Principal investigator: Konstantinos BACHOUMAS, MD — Hospital, La Roche sur Yon
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.