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Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00847314
Enrollment
30
Registered
2009-02-19
Start date
2007-06-30
Completion date
2008-10-31
Last updated
2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

Hypogonadism, Abdominal obesity, Physical exercise, Testosterone

Brief 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.

Interventions

Male patients \> 35yrs in medical practices fulfilling all criteria for documentation.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
35 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Male patients \> 35yrs * Waist Circumference \> 102cm * Clinically and biochemically confirmed hypogonadism (testosterone group) * Willingness to attempt weight optimization

Exclusion criteria

* Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours * hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

Design outcomes

Primary

MeasureTime frame
Waist CircumferenceAt each visit

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026