Older Men and Testosterone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00119483
First received: July 5, 2005
Last updated: September 2, 2011
Last verified: September 2011
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00119483     History of Changes
Other Study ID Numbers: Eldre menn og testosteron
Study First Received: July 5, 2005
Last Updated: September 2, 2011
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

Additional relevant MeSH terms:
Hypogonadism
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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014