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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847314
• Other study ID #: 13899
• Secondary ID: NE0602
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: June 19, 2013
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients > 35yrs in medical practices fulfilling all criteria for documentation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist Circumference		At each visit	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.