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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

June 16, 2008
September 18, 2009
April 2008
January 2010   (final data collection date for primary outcome measure)
Lean body mass [ Time Frame: january 2008-january 2010 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700024 on ClinicalTrials.gov Archive Site
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 ]
Insulin sensitivity Viceral fat/liver fat Body fat Waist Physical conditions and physical strenghts Adiponectin Lipid metabolism Subjective sensation of energy Urine cortisol Sexual function Serum testosterone [ Time Frame: january 2008-january 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men
The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

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

The effect of testim and training in hypogonadal men.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypogonadism
  • Metabolic Syndrome
  • Drug: Testim
    50 mg/dose7day
    Other Name: testosteron
  • Behavioral: Strength training
    three times a week
    Other Name: training
  • Drug: placebo
    placebo
    Other Name: gel
  • Active Comparator: 1
    testim
    Intervention: Drug: Testim
  • Experimental: 2
    placebo
    Intervention: Drug: placebo
  • Experimental: 3
    training
    Intervention: Behavioral: Strength training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Male
65 Years to 78 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00700024
030
Yes
Marianne Andersen, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Marianne Andersen, Md, phd
Odense University Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP