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Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00700024
First received: June 16, 2008
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to determine the effect of training and testim on Hypogonadism.


Condition Intervention Phase
Hypogonadism
Metabolic Syndrome
 Drug: Testim
Behavioral: Strength training
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: january 2008-january 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone [ Time Frame: january 2008-january 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
testim
 Drug: Testim
50 mg/dose7day
Other Name: testosteron
Experimental: 2
placebo
 Drug: placebo
placebo
Other Name: gel
Experimental: 3
training
 Behavioral: Strength training
three times a week
Other Name: training

Detailed Description:

The effect of testim and training in hypogonadal men.

  Eligibility

Ages Eligible for Study:   65 Years to 78 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male 65-78
  • Bioavailable testosterone < 7.3 nmol/L
  • Waist > 94 cm

Exclusion Criteria:

  • Haematocrit > 0.50
  • Known c. prostate or PSA > 3 Myg/L
  • Known malignant disease
  • Alcohol or drug abuse
  • BMI > 40 kg/m2
  • Use of 5 alpha reductance inhibitors
  • Plan to father children
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700024

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, Md, phd
  More Information

No publications provided

Responsible Party: Marianne Andersen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00700024     History of Changes
Other Study ID Numbers: 030
Study First Received: June 16, 2008
Last Updated: September 18, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Body composition
Physical activity
Metabolic syndrome

Additional relevant MeSH terms:
Hypogonadism
Metabolic Syndrome X
Gonadal Disorders
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
 Testosterone enanthate
Testosterone undecanoate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens

ClinicalTrials.gov processed this record on May 16, 2013