Testosterone in bariatric patients
- Registration Number
- EUCTR2018-002365-19-DK
- Lead Sponsor
- ine Velling Magnussen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 50
-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) [41]
-Caucasian men
-Total testosterone < 12.0 nmol/l
-No contraindications for testosterone treatment
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years.
-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%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method