A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention)

Table 4 Study Endpoints

Systemic effects - Glucose metabolism (fasting glucose, 2 h glucose, insulin, hemoglobin a1c, HOMA-index) - Cholesterol (high density lipoprotein-cholesterol, low density lipoprotein-cholesterol, total cholesterol) - Inflammatory markers (interleukin 1-β, interleukin-6, interleukin-8, tumour necrotic factor-alpha) - Adipocytokines (adiponectin, leptin) - Reproductive hormones (total testosterone, free testosterone, luteinizing hormone)
Body composition and bone mineral density - Whole body bone mineral density, whole body t-score, t-score of the lumbar spine and proximal femoral bone - Lean body mass - Whole body fat percent (Z-score) - Visceral adiposity, android fat distribution, gynoid fat distribution
Anthropomorphic measures - Waist circumference - Hip circumference - Body mass index - Anogenital distance
Patient reported outcomes - Health related quality of Life (EORTC QLQ-C30) - Anxiety and Depression: (Hospital Depression and Anxiety Scale) - Fatigue: (Multiple Fatigue Inventory-20) - Symptoms of testosterone deficiency and erectile dysfunction: (International Index of Erectile Function-15)

Abbreviations: HOMA-index Homeostasis model assessment index, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

ISSN: 1471-2407