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Sponsored by: |
University Hospital of North Norway |
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Information provided by: | University Hospital of North Norway |
ClinicalTrials.gov Identifier: | NCT00119483 |
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 |
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Hypogonadism |
Drug: Nebido (Testosterone Undecanoate) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 200 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Medicine, University Hospital of North Norway | |
Tromsø, Norway, 9038 |
Principal Investigator: | Johan Svartberg, MD, PhD | University Hospital of North Norway |
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 |
Men testosterone hypogonadal aging |
body composition quality og life Muscle strength Aging male |
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 |
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 |