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Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial.
EU CTIS ID: 2024-519156-93-00
What this study is testing
To demonstrate that daily administration of testosterone gel, 101.25 mg in men and 20.25 mg in women, during the acute phase of critical illness, is more effective than placebo in improving physical performance 3 months after ICU admission.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females aged over 18 years
- Negative pregnancy test (b-HCG) in female patient of childbearing potential
- COVID-19 or not
- Patient on invasive mechanical ventilation for an expected total duration of at least 48 hours and still on invasive mechanical ventilation at the time of inclusion.
- Written informed consent obtained from the patient or the legal representative
- Social security cover
You likely can't join if
- History of prostate cancer
- Breast feeding
- Patients under legal guardianship
- History of breast cancer
- Prostate cancer suspected or confirmed
- Breast cancer suspected or confirmed
See the full eligibility criteria
- Males and females aged over 18 years
- Negative pregnancy test (b-HCG) in female patient of childbearing potential
- COVID-19 or not
- Patient on invasive mechanical ventilation for an expected total duration of at least 48 hours and still on invasive mechanical ventilation at the time of inclusion.
- Written informed consent obtained from the patient or the 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
- History of prostate cancer
- Breast feeding
- Patients under legal guardianship
- History of breast cancer
- Prostate cancer suspected or confirmed
- Breast cancer suspected or confirmed
- PSA ≥ 4 ng/ml
- ICU length of stay > 120 h before enrollment
- Moribund
- Pre-existing illness with a life expectancy of <6 months not connected to the acute pathology justifying ICU admission
- Recent intracranial or spinal cord injury (< 1 month)
- Recent hemorrhagic or ischemic stroke (< 1 month)
- Language barrier
- Patient deprived of liberty
- Neuromuscular disease
- Cardiac arrest in non-shockable rhythm
- Pre-existing cognitive impairment with an MMS score < 20
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.