Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT05825092
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05825092
Study Brief:
Protocol Section:
NCT05825092