Trial Condition(s):
Hypogonadism
Efficacy and tolerability of Testogel/Nebido in combination with exercise and diet in hypogonadal male patients
Bayer Identifier:
13899
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Waist CircumferenceTimeframe: At each visit
Additional Information
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