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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700024
Recruitment Status : Unknown
Verified September 2009 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : September 21, 2009
Information provided by:
Odense University Hospital

June 16, 2008
June 18, 2008
September 21, 2009
April 2008
January 2010   (Final data collection date for primary outcome measure)
Lean body mass [ Time Frame: january 2008-january 2010 ]
Same as current
Complete list of historical versions of study NCT00700024 on 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 ]
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 ]
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
    Other Name: gel
  • Active Comparator: 1
    Intervention: Drug: Testim
  • Experimental: 2
    Intervention: Drug: placebo
  • Experimental: 3
    Intervention: Behavioral: Strength training

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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
Sexes Eligible for Study: Male
65 Years to 78 Years   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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