Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients

Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients. An open-label parallel randomized controlled pilot study - TestICU-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004978-34-FR

Enrollment

Registered

2018-08-03

Start date

2018-12-04

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Pharmaceutical Form: Trade Name: Androgel 16.2 mg/g is a transparent or slightly opalescent, colourless gel with an odour of alcohol. One gram of gel contains 16.2 mg testosterone. One pump actuatio

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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 80 years • Pregnancy or breast feeding • Patient under legal guardianship

Design outcomes

Primary

Measure	Time frame
Main Objective: •To demonstrate that administration of 101.25 mg/day of testosterone gel in men and 20.25 mg/day in women, during the acute phase of critical illness, can restore normal serum values of total testosterone from day 4 to day 14.;Secondary Objective: •Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women •Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women •Safety of testosterone gel •Daily and cumulative nitrogen balance from day 1 to extubation •Physical performance at ICU discharge, 1month and 3 months after ICU discharge •Muscle strength at ICU discharge, 1month and 3 months after ICU discharge •Near Infrared Spectroscopy (NIRS) at ICU discharge •Muscular mass at ICU discharge and one month after ICU discharge •Lung function at 1 and 3 months after ICU discharge ;Primary end point(s): •Proportion of patients with median value of serum total testosterone collected from blood samples at day 4, 7, 10, 14 higher than 280 ng/dl in men and 12 ng/dl in women. ;Timepoint(s) of evaluation of this end point: from day 4 to day 14 after inclusion	—

Measure

Time frame

Main Objective: •To demonstrate that administration of 101.25 mg/day of testosterone gel in men and 20.25 mg/day in women, during the acute phase of critical illness, can restore normal serum values of total testosterone from day 4 to day 14.;Secondary Objective: •Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women •Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women •Safety of testosterone gel •Daily and cumulative nitrogen balance from day 1 to extubation •Physical performance at ICU discharge, 1month and 3 months after ICU discharge •Muscle strength at ICU discharge, 1month and 3 months after ICU discharge •Near Infrared Spectroscopy (NIRS) at ICU discharge •Muscular mass at ICU discharge and one month after ICU discharge •Lung function at 1 and 3 months after ICU discharge ;Primary end point(s): •Proportion of patients with median value of serum total testosterone collected from blood samples at day 4, 7, 10, 14 higher than 280 ng/dl in men and 12 ng/dl in women. ;Timepoint(s) of evaluation of this end point: from day 4 to day 14 after inclusion

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women • Proportion of patients with median serum values of bioavailable testosterone • throughout the duration of the study • day 1 to extubation • at ICU discharge, 1month and 3 months after ICU discharge • at ICU discharge, 1month and 3 months after ICU discharge at ICU discharge • at ICU discharge and one month after ICU discharge • at 1 and 3 months after ICU discharge ;Secondary end point(s): • Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women • Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women • Safety of testosterone gel • Daily and cumulative nitrogen balance from day 1 to extubation • Physical performance at ICU discharge, 1month and 3 months after ICU discharge • Muscle strength at ICU discharge, 1month and 3 months after ICU discharge • Near Infrared Spectroscopy (NIRS) at ICU discharge • Muscular mass at ICU discharge and one month after ICU discharge • Lung function at 1 and 3 months after ICU discharge	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women • Proportion of patients with median serum values of bioavailable testosterone • throughout the duration of the study • day 1 to extubation • at ICU discharge, 1month and 3 months after ICU discharge • at ICU discharge, 1month and 3 months after ICU discharge at ICU discharge • at ICU discharge and one month after ICU discharge • at 1 and 3 months after ICU discharge ;Secondary end point(s): • Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women • Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women • Safety of testosterone gel • Daily and cumulative nitrogen balance from day 1 to extubation • Physical performance at ICU discharge, 1month and 3 months after ICU discharge • Muscle strength at ICU discharge, 1month and 3 months after ICU discharge • Near Infrared Spectroscopy (NIRS) at ICU discharge • Muscular mass at ICU discharge and one month after ICU discharge • Lung function at 1 and 3 months after ICU discharge

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Countries

France

Contacts

Public ContactPatrick Lacarin

DRCI

placarin@chu-clermontferrand.fr00330473751195

Outcome results