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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00847314
First received: February 17, 2009
Last updated: June 19, 2013
Last verified: June 2013
  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)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Waist Circumference [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Enrollment: 30
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00847314     History of Changes
Other Study ID Numbers: 13899, NE0602
Study First Received: February 17, 2009
Last Updated: June 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Hypogonadism
Abdominal obesity
Physical exercise
Testosterone

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 29, 2014