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

September 18, 2009 updated by: Odense University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The effect of testim and training in hypogonadal men.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 78 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
testim
Drug: Testim
50 mg/dose7day
Other Names:
  • testosteron
Experimental: 2
placebo
Drug: placebo
placebo
Other Names:
  • gel
Experimental: 3
training
Behavioral: Strength training
three times a week
Other Names:
  • training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lean body mass
Time Frame: january 2008-january 2010
january 2008-january 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
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
january 2008-january 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Marianne Andersen, Md, phd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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