Older Men and Testosterone

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of North Norway
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.