Older Men and Testosterone
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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 |
- Quality of life (psycho-sexual)
- Muscle strength
- 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 |
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| Norway | |
| Department of Medicine, University Hospital of North Norway | |
| Tromsø, Norway, 9038 | |
| 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 May 22, 2013