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

NCT00847314 | Completed

• 2 other identifiers: 13899NE0602
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypogonadism

Keywords

Hypogonadism; Abdominal obesity; Physical exercise; Testosterone

Outcome Measures

Primary Outcomes (1)

• Waist Circumference

  At each visit

Study Arms (1)

Group 1

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

Interventions

Testosterone Undeconate (Nebido-R, BAY86-5037) DRUG

Male patients \> 35yrs in medical practices fulfilling all criteria for documentation.

Group 1

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male patients in medical practices \> 35yrs fulfilling all criteria for documentation.

You may qualify if:

• Male patients \> 35yrs
• Waist Circumference \> 102cm
• Clinically and biochemically confirmed hypogonadism (testosterone group)
• Willingness to attempt weight optimization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Hypogonadism; Obesity, Abdominal; Motor Activity

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

DE (1)