Status:
COMPLETED
Short-term Testosterone Replacement in Testicular Cancer Survivors
Lead Sponsor:
University Medical Center Groningen
Conditions:
Testicular Cancer
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an op...
Detailed Description
Rationale: Testicular cancer (TC) survivors have an increased risk of hypogonadism (decreased testosterone and/or increased luteinizing hormone levels) and cardiovascular disease (CVD). Metabolic synd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03339635
Start Date
December 21 2018
End Date
June 26 2024
Last Update
July 30 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ