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Muscle strength and -mass after bariatric surgery - a possible effect of testosterone replacement therapy? Randomized, placebo-controlled and double-blinded study
EU CTIS ID: 2024-517015-73-00
What this study is testing
To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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) - Caucasian men - Total testosterone < 12.0 nmol/l - No contraindications for testosterone treatment
You likely can't join if
- 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% - The following treatments are not allowed in the study:5-α-reductase inhibitors and Prednisolone >5mg/day
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.