Last updated: April 13, 2023
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting
Phase
2
Condition
Hypogonadism
Treatment
N/AClinical Study ID
NCT03678233
CHU-404
2017-004978-34
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females aged over 18 years receiving invasive mechanical ventilation
- Invasive mechanical ventilation expected to be required for more than 48 hours
- Treatment with vasoactive drugs
- Written informed consent obtained from the legal representative
- Social security cover
Exclusion
Exclusion Criteria:
- History of prostate or breast cancer, prostatic specific antigen (PSA) ≥ 4 ng/ml
- ICU length of stay > 72 h before enrollment
- Moribund defined as having a score SAPS II > 75 12 hours after admission
- Pre-existing illness with a life expectancy of <6 months
- Cardiac arrest
- Preexistent cognitive impairment or language barrier
- Acute intracranial or spinal cord injury
- Acute hemorrhagic or ischemic stroke
- Neuromuscular disease (Guillain-Barré, myasthenia)
- Inability to walk without assistance prior to acute ICU illness (use of a cane orwalkers not excluded)
- Documented allergy to testosterone
- Age > 80 years
- Pregnancy or breast feeding
- Patient on judicial protection
Study Design
Total Participants: 30
Study Start date:
June 27, 2019
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
FranceActive - Recruiting
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