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Can testosterone shield muscle during rapid weight loss?

NCT ID NCT03721497

Symptom relief Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Bariatric surgery helps people with severe obesity lose weight, but it also strips away muscle and bone. Many men who have the surgery also have low testosterone, which worsens muscle loss. This trial tests whether testosterone replacement, combined with exercise and diet counselling, preserves muscle strength and lean mass in hypogonadal men before and after surgery. Sixty-four men receive either testosterone or a placebo, and researchers track changes in shoulder strength, body composition, bone density, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone undecanoate, a long-acting testosterone replacement therapy
What this could lead to
If it works, testosterone therapy could become a standard add-on for men with low testosterone who lose muscle during rapid weight loss after bariatric surgery.
What could go wrong
This is a small, single-centre Phase 4 trial of 64 men, so results may not apply broadly. Testosterone can raise red blood cell counts and may carry prostate risks, and muscle benefits may fade once treatment stops.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

64 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18-60 years, BMI \>35 kg/m2 with specific secondary disease or BMI \>40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) \[42\] * Caucasian men * Total testosterone \< 12.0 nmol/l * No contraindications for testosterone treatment Exclusion Criteria: * Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years. * Hypersensitivity to the active substance or to any of the excipients in Nebido® * Symptomatic heart disease NYHA \>2 * Recently thromboembolic disease \<3 months * PSA \>4.0 ug/l or PSA\>3.0 ug/l and lower urinary tract symptoms * Disability that severely affect the ability to perform exercise training * EVF \> 52%

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Conditions

The condition(s) this trial relates to.

eunuchism hypogonadism, male muscular atrophy obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery candidate Male hypogonadism Muscle loss

Contacts and locations

Locations

  • HospitalSWD

    Esbjerg, 6700, Denmark

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