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

Bayer

Status: Completed

Conditions: Hypogonadism

Treatments: Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

Study type: Observational

Funder types: Industry

Identifiers

NCT00847314

13899

NE0602 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 35 to 64 years old

Volunteers: No Healthy Volunteers

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 design

30 participants in 1 patient group

Group 1

Treatment:

Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)