Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00847314

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.

Condition	Intervention
Hypogonadism	Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Waist Circumference [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	50
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Testosterone Undeconate (Nebido-R, BAY86-5037) Male patients > 35yrs in medical practices fulfilling all criteria for documentation.

Eligibility

Ages Eligible for Study:	35 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847314

Locations

Germany

Many locations, Germany

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Director )
Study ID Numbers:	13899, NE0602
Study First Received:	February 17, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00847314 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Hypogonadism
Abdominal obesity
Physical exercise
Testosterone

Study placed in the following topic categories:

Obesity
Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone

Hormones
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Endocrinopathy
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on May 07, 2009