Short-term Testosterone replacement in testicular cancer survivors to treat overweight and improve cardiometabolic risk

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 50

Inclusion Criteria

We will include patients with metastatic testicular cancer after chemotherapy, at least 12 months after completion of last treatment and without evidence of disease. Combination chemotherapy should have contained a platinum compound, either cisplatin or carboplatin. In TC survivors, testosterone levels are routinely measured in blood during follow-up once every two years. Patients are eligible for screening if they are between 18 and 55 years of age, and have a documented low or low-normal total testosterone level =14 nmol/L, as measured during any of the follow-up visits, irrespective of signs and symptoms of androgen deficiency. Eligible for actual study participation and randomization between Androgel and placebo will be: survivors of TC not using testosterone supplements, having biochemical evidence of hypogonadism (defined as a serum total testosterone concentration = 12 nmol/L (345 ng/dL) measured after an overnight fast between 8:00 and 10:00 AM), and being overweight (as defined by a BMI = 25 and <35 kg/m2). Patients should be able to understand and abide to the study protocol and sign written informed consent.
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

Exclusion Criteria

We will exclude: patients planning to father children within the next 12 months; patients already treated for hypogonadism, patients taking corticosteroids or hormone replacement other than testosterone with dose-adjustments within the last 3 months prior to randomization; patients taking medication with any antiandrogenic effects (e.g. spironolactone); patients with signs or history of hormone-dependent cancer (prostate or breast cancer); patients with severe lower urinary tract symptoms (as defined by International Prostate Symptom Score >19); patients with a history of coronary artery disease (angina pectoris, myocardial infarction) or heart failure; patients with hematocrit >50%; patients with untreated severe obstructive sleep apnea; patients with uncontrolled hypertension; patients with a BMI > 35 kg/m2; patients with a history of epilepsy; patients with debilitating psychiatric illness or inability to understand the study protocol, according to the opinion of the investigator.

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

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