A Phase 2/3 interventional study of Testosterone and Placebos in Metabolic Syndrome, Testicular Cancer and Leydig Cell Failure in Adult, sponsored by Mikkel Bandak. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Mikkel Bandak · Phase 2/3, Interventional, and Treatment
The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.
This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.
70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).
189 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.
This study's enrollment of 69 is above the median of 59 across 122 interventional studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →This is the only study on the registry with Mikkel Bandak as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 years treatment with transdermal Tostran 2%
Drug: Testosterone
1 years treatment with placebo gel
Drug: Placebos
Also known as: Tostran
Changes in insulin sensitivity
Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)
Time frame: 1 year
Changes in fasting plasma lipids between baseline and 52 weeks
Time frame: 1 year
Changes in BMD and fat percent between baseline 52 weeks
BMD and body composition evaluated by DXA-scan
Time frame: 1 year
Changes in systemic inflammation between baseline and 52 weeks
Analysis of tnf-alfa, interleukine 1-beta, interleukine 1, interleukine 6, interleukine 8
Time frame: 1 year
Changes in plasma-adipocytokines between baseline and 52 weeks
Time frame: 1 year
Changes in fasting plasma glucose between baseline and 52 weeks
Time frame: 1 year
Changes in Quality of life between baseline and 52 weeks.
EORTC-QLQ C30
Time frame: 1 year
Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0
Time frame: 1 year
Changes in prevalence of metabolic syndrome between baseline and 52 weeks
According to NCEP-ATPIII criteria
Time frame: 1 year
Changes in haemoglobin A1c between baseline and 52 weeks
Time frame: 1 year
Changes in plasma insulin between baseline and 52 weeks
Time frame: 1 year
Changes in fatigue between baseline and 52 weeks
MFI-20 (Multidimensional Fatigue Inventory)
Time frame: 1 year
Changes in Anxiety and depression between baseline and 52 weeks
HADS (Hospital Anxiety and Depression Scale)
Time frame: 1 year
Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks
IIEF-15 (International Index of Erectile Dysfunction)
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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