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.

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Key information

Conditions

Hypogonadism Behavior Body Weight Endocrine System Diseases Gonadal Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–64 year

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone Undeconate (Nebido-R, BAY86-5037)

Drug

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

Primary outcomes

Waist Circumference

Time frame: At each visit

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Feb 19, 2009
Registry last updated: Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed