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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Odense University Hospital

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

Condition or disease Intervention/treatment Phase
Hypogonadism Metabolic Syndrome Drug: Testim Behavioral: Strength training Drug: placebo Phase 4

Detailed Description:
The effect of testim and training in hypogonadal men.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : February 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Lean body mass [ Time Frame: january 2008-january 2010 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   65 Years to 78 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700024


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marianne Andersen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00700024     History of Changes
Other Study ID Numbers: 030
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

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

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