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Older Men and Testosterone

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: NCT00119483
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : September 5, 2011
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:

Male hypogonadism is a clinical situation characterized by a low serum testosterone level in combination with a diversity of symptoms and signs such as reduced libido and vitality, decreased muscle mass, increased fat mass and depression. Similar symptoms in combination with subnormal testosterone levels are seen in some elderly men. Low testosterone levels are associated with known cardiovascular risk factors, and men with diabetes and stroke have lower testosterone levels than healthy men. Even though several publications have suggested that testosterone treatment in hypogonadal men may have beneficial effects, it is still uncertain if testosterone substitution in the aging man is indicated. Despite this uncertainty the sale of testosterone has increased enormously the last few years.

We hypothesize that older men with subnormal testosterone levels have a varying degree of dysfunction/symptoms both physically and mentally, and that these dysfunction/symptoms can be improved with testosterone treatment.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Nebido (Testosterone Undecanoate) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Quality of life (psycho-sexual)
  2. Muscle strength

Secondary Outcome Measures :
  1. Body composition
  2. Muscle function
  3. Intra abdominal vs subcutanous fat mass.
  4. Bone density
  5. CAG and GGN polymorphy in the androgene receptor gene
  6. Glucose tolerance/insulin resistance
  7. Fat tolerance
  8. Neuroendocrine profile
  9. Neuropsychological profile
  10. Sleep

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men 60-80 years old
  • Serum-testosterone levels <11.0 nmol/l
  • Signed informed consent.

Exclusion Criteria:

  • Prostate cancer
  • Breast cancer
  • Liver tumor/cancer
  • Unstable angina
  • Untreated congestive heart disease
  • Epilepsy
  • Migraine
  • Hematocrit >50%
  • PSA >4.0 ug/l
  • Serum creatinine >130 umol/l
  • ALAT >100 U/l
  • Known intolerance to testosterone undecanoate
  • Participation in another research trial.

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 identifier (NCT number): NCT00119483

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Department of Medicine, University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
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Principal Investigator: Johan Svartberg, MD, PhD University Hospital of North Norway
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Responsible Party: University Hospital of North Norway Identifier: NCT00119483    
Other Study ID Numbers: Eldre menn og testosteron
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011
Keywords provided by University Hospital of North Norway:
body composition
quality og life
Muscle strength
Aging male
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents