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Trial record 97 of 213 for:    "Hypogonadism" | "Androgens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847314
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : June 21, 2013
Information provided by:

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.

Condition or disease Intervention/treatment
Hypogonadism Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: 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
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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

Primary Outcome Measures :
  1. Waist Circumference [ Time Frame: At each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847314

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Many locations, Germany
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Medical Director, Bayer Schering Pharma AG Identifier: NCT00847314     History of Changes
Other Study ID Numbers: 13899
NE0602 ( Other Identifier: Other company ID )
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Bayer:
Abdominal obesity
Physical exercise
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents