Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effects of Testosterone Gel on Physical Performance in Critically Ill Patients Requiring Long-Term Mechanical Ventilation

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who are critically ill and require invasive mechanical ventilation for more than 48 hours. The study is investigating the effects of a treatment using a gel called ANDROGEL, which contains the active substance testosterone. Testosterone is a hormone that plays a key role in physical performance and muscle strength. The trial aims to see if applying this gel daily can improve physical performance three months after being admitted to the intensive care unit (ICU) compared to a placebo gel, which does not contain active ingredients.

Participants in the study will receive either the testosterone gel or the placebo gel for a period of up to 28 days. The study will monitor the physical performance of participants at different intervals: three months, six months, and one year after ICU admission. This will include tests like the six-minute walk distance test, which measures how far a person can walk in six minutes. The study will also look at muscle strength, muscle mass, and overall functional status over time. Additionally, the safety of the testosterone gel will be assessed by monitoring for any side effects such as high blood pressure, cardiovascular events, or changes in blood cell counts.

The purpose of this study is to determine if early administration of testosterone gel can help improve recovery and physical performance in critically ill patients. The trial will also track other outcomes such as the number of days patients are free from ventilation, the length of stay in the ICU and hospital, and mortality rates. The study is expected to continue until July 2027, with the goal of providing valuable insights into the potential benefits of testosterone treatment in this patient group.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed based on criteria such as age over 18, a negative pregnancy test for women of childbearing potential, and the expectation of requiring mechanical ventilation for more than 48 hours.

    Informed consent is obtained from the patient or their legal representative.

  2. Step 2

    Treatment phase

    During the acute phase of critical illness, a daily administration of testosterone gel is provided.

    The dosage is 101.25 mg for men and 20.25 mg for women, applied through the skin.

    A placebo may be administered instead, as part of the study's design.

  3. Step 3

    Monitoring and assessment

    Physical performance is assessed 3 months after ICU admission using the 6-minute-walk distance test.

    Additional assessments occur at 3, 6 months, and 1 year after ICU admission, including muscle strength, muscle mass, and functional status.

    Safety of the testosterone gel is monitored, checking for side effects such as hypertension, cardiovascular events, and other potential issues.

  4. Step 4

    Follow-up evaluations

    Further evaluations of physical performance, muscle strength, and functional status are conducted at 6 months and 1 year after ICU admission.

    The study also tracks outcomes such as ventilation-free days, length of stay in the ICU and hospital, and mortality rates at various intervals.

Who can join the trial?

8 criteria

  • Participants must be **males or females** aged over 18 years.
  • Female participants who can have children must have a **negative pregnancy test** before joining the study.
  • Participants can have **COVID-19** or not; both are eligible.
  • Participants must need **invasive mechanical ventilation** for more than 48 hours. This means they will need a machine to help them breathe for more than two days.
  • Participants or their legal representatives must provide **written informed consent**. This means they agree to join the study after understanding what it involves.
  • Participants must have **social security cover**. This is a form of insurance or government support for health care.
  • Female participants who can have children must agree to use a **highly effective method of contraception** during the study and for 7 months after the last treatment. Their male partners must also use effective contraception.
  • Male participants with female partners who can have children must agree to use a **highly effective method of contraception** during the study and for 4 months after the last treatment. Their female partners must also use effective contraception.

Who cannot join the trial?

1 criterion

  • If you are expected to need **invasive mechanical ventilation** for more than 48 hours, you cannot participate. This means if you need a machine to help you breathe for more than two days, you are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Testosterone Gel is being tested in this clinical trial to see if it can help improve physical performance in people who are critically ill. The trial is looking at how effective daily use of this gel is during the early stages of critical illness. The goal is to see if it can make a difference in how well patients perform physically three months after being admitted to the intensive care unit (ICU).

What is already known about the treatment

Testosterone Gel – This medication is administered topically as a gel applied to the skin. It is currently being studied in clinical trials to assess its effectiveness in improving physical performance in critically ill patients who require invasive mechanical ventilation for more than 48 hours. The main therapeutic indication is to enhance physical recovery in these patients. At the molecular level, testosterone works by binding to androgen receptors, influencing gene expression, and promoting protein synthesis, which can aid in muscle strength and recovery. It is classified as an androgen and anabolic steroid.

Investigated diseases

Invasive Mechanical Ventilation – This is a medical procedure used to assist or replace spontaneous breathing when a person is unable to breathe on their own. It involves the use of a machine called a ventilator, which delivers air into the lungs through a tube inserted into the windpipe. The need for this procedure can arise from various conditions, such as severe respiratory distress or failure. Over time, patients may experience muscle weakness due to prolonged use of the ventilator. The process of weaning off the ventilator can be gradual, depending on the patient's recovery and ability to breathe independently. Monitoring and support are essential to ensure the patient's safety and comfort during this period.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519156-93-00Protocol codePHRC N2018 BACHOUMASEstimated enrolment600 patientsSponsorUniversity Hospital Of Clermont-Ferrand

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).