Trial Condition(s):

Hypogonadism

Efficacy and tolerability of Testogel/Nebido in combination with exercise and diet in hypogonadal male patients

Bayer Identifier:

13899

ClinicalTrials.gov Identifier:

NCT00847314

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
30
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Germany

Status
Completed
 

Trial Design