Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
NCT00847314 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2013-06-21
Summary
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.
Conditions
- Hypogonadism
Interventions
- DRUG
-
Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients \> 35yrs in medical practices fulfilling all criteria for documentation.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Eligibility
- Min Age
- 35 Years
- Max Age
- 64 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2008-10-31
- Completion
- 2008-10-31
Countries
- Germany
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