- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847314
Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
June 19, 2013 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many locations, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male patients in medical practices > 35yrs fulfilling all criteria for documentation.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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Male patients > 35yrs in medical practices fulfilling all criteria for documentation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist Circumference
Time Frame: At each visit
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At each visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 19, 2009
Study Record Updates
Last Update Posted (Estimate)
June 21, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 13899
- NE0602 (Other Identifier: Other company ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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