Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme|
- Waist Circumference [ Time Frame: At each visit ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients > 35yrs in medical practices fulfilling all criteria for documentation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847314
|Many locations, Germany|
|Study Director:||Bayer Study Director||Bayer|