check_circleStudy Completed

Hypogonadism

Bayer Identifier:

13899

ClinicalTrials.gov Identifier:

NCT00847314

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and tolerability of Testogel/Nebido in combination with exercise and diet in hypogonadal male patients

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.

Key Participants Requirements

Sex

Male

Age

35 - 64 Years
  • - Male patients > 35yrs
    - Waist Circumference > 102cm
    - Clinically and biochemically confirmed hypogonadism (testosterone group)
    - Willingness to attempt weight optimization
  • - 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
30
Trial Dates
June 2007 - October 2008
Phase
N/A
Could I Receive a placebo
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Germany

Primary Outcome

  • Waist Circumference
    date_rangeTime Frame:
    At each visit
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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