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Clinical Trials/EUCTR2019-004599-20-FR
EUCTR2019-004599-20-FR
Active, not recruiting
Phase 1

Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial - TestICUs

CHU DE CLERMONT-FERRAND0 sites600 target enrollmentMay 25, 2021

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHU DE CLERMONT-FERRAND
Enrollment
600
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 25, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHU DE CLERMONT-FERRAND

Eligibility Criteria

Inclusion Criteria

  • Males and females aged over 18 years
  • COVID\-19 or not
  • Invasive mechanical ventilation expected to be required for more than 48 hours
  • Written informed consent obtained from the patient or the legal representative
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 400
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 200

Exclusion Criteria

  • History of prostate cancer
  • History of breast cancer
  • PSA \= 4 ng/ml
  • ICU length of stay \> 120 h before enrollment
  • Pre\-existing illness with a life expectancy of \<6 months
  • Recent intracranial or spinal cord injury (\< 1 month)
  • Recent hemorrhagic or ischemic stroke( \< 1 month)
  • Neuromuscular disease
  • Cardiac arrest in non\-shockable rhythm
  • Pre\-existing cognitive impairment or language barrier

Outcomes

Primary Outcomes

Not specified

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