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New treatment option for Critical Illness
Official title Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill
ClinicalTrials.gov ID: NCT05825092
What this study is testing
What is Androgel Topical Product?
Androgel Topical Product is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for critical illness.
Also referred to as Androgel 1.62% Transdermal Gel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Critically ill patients experience major insults that lead to increased protein catabolism. Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
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
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Clermont-Ferrand, France
- La Roche-sur-Yon, France
- Nantes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Clermont-Ferrand, France; La Roche-sur-Yon, France; Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.