Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT03339635
Eligibility Criteria:
Inclusion Criteria:
* patients with metastatic testicular cancer after unilateral orchidectomy and 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
* 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.
Exclusion Criteria:
* patients with a history of extragonadal testicular cancer
* patients planning to father children within the next 12 months
* patients taking corticosteroids or hormone replacement other than testosterone within 3 months of 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03339635
Study Brief:
Protocol Section:
NCT03339635