ACTRN12613000613707
Completed
Phase 3
Effect of Testosterone Therapy Combined with Very Low Caloric Diet on Weight Loss and Weight Maintenance in Obese Men: A Randomized Controlled Trial
niversity of Melbourne0 sites100 target enrollmentMay 29, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Melbourne
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male sex, age 18\-75 years, BMI 30\-60 kg/m2and testosterone \<12nmol/
Exclusion Criteria
- •established pituitary or testicular disorders, contraindications to testosterone therapy including androgen\-dependent carcinoma of the prostate or of the male mammary gland, known malignancy, hypersensitivity to the active substance or to any of the excipients, polycythemia (haematocrit\>55%), known liver tumour, significant benign prostate hypertrophy, prostate specific antigen (PSA) \> 4ng/ml, uncontrolled hypertension (\>160/90 mm Hg despite anti\-hypertensive medication, uncontrolled untreated sleep apnoea, severe disturbance in renal function (estimated glomerular filtration rate \<30 ml/min), uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association performance status \>2\), coagulation disorders, current use of weight\-altering medications (thiazolidinediones, systemic glucocorticoids, antipsychotics, topiramate), unstable thyroid dysfunction (stable \= normal TFT on thyroxine dose \>3/12\), Cushing’s disease; past history of bariatric surgery
Outcomes
Primary Outcomes
Not specified
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