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Older Men and Testosterone
This study is ongoing, but not recruiting participants.
First Received: July 5, 2005   Last Updated: January 22, 2007   History of Changes
Sponsored by: University Hospital of North Norway
Information provided by: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00119483
  Purpose

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 Intervention
Hypogonadism
Drug: Nebido (Testosterone Undecanoate)

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Quality of life (psycho-sexual)
  • Muscle strength

Secondary Outcome Measures:
  • Body composition
  • Muscle function
  • Intra abdominal vs subcutanous fat mass.
  • Bone density
  • CAG and GGN polymorphy in the androgene receptor gene
  • Glucose tolerance/insulin resistance
  • Fat tolerance
  • Neuroendocrine profile
  • Neuropsychological profile
  • Sleep

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119483

Locations
Norway
Department of Medicine, University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Principal Investigator: Johan Svartberg, MD, PhD University Hospital of North Norway
  More Information

No publications provided

Study ID Numbers: Eldre menn og testosteron
Study First Received: July 5, 2005
Last Updated: January 22, 2007
ClinicalTrials.gov Identifier: NCT00119483     History of Changes
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University Hospital of North Norway:
Men
testosterone
hypogonadal
aging
body composition
quality og life
Muscle strength
Aging male

Study placed in the following topic categories:
Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones
Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Hypogonadism
Endocrinopathy
Androgens

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on May 07, 2009