drugset / Trial / NCT02514629
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
Phase 3
Completed
107 enrolled
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo
Timeline
- Start
- 2013-07-04
- Primary completion
- 2016-07-12
- Completion
- 2016-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 850 mg | Oral |
| Subject | Testosterone Undecanoate | Small molecule | 1000 mg | Intramuscular |