Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
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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 |
- Waist Circumference [ Time Frame: At each visit ] [ Designated as safety issue: No ]
| 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 |
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.
Contacts and Locations 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: | February 18, 2009 |
| 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 Obesity, Abdominal Gonadal Disorders Endocrine System Diseases Obesity Overnutrition Nutrition Disorders 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 26, 2012
