Older Men and Testosterone

NCT00119483 | Completed

• 1 other identifier: Eldre menn og testosteron
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism

Keywords

Men; testosterone; hypogonadal; aging; body composition; quality og life; Muscle strength; Aging male

Outcome Measures

Primary Outcomes (2)

• Quality of life (psycho-sexual)

• Muscle strength

Secondary Outcomes (10)

• Body composition

• Muscle function

• Intra abdominal vs subcutanous fat mass.

• Bone density

• CAG and GGN polymorphy in the androgene receptor gene

Interventions

Nebido (Testosterone Undecanoate) DRUG

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 60-80 years old
• Serum-testosterone levels \<11.0 nmol/l
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

Department of Medicine, University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Hypogonadism; Multiple Endocrine Neoplasia Type 1

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Johan Svartberg, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 13, 2005
• Study Start: September 1, 2005
• Study Completion: December 1, 2007
• Last Updated: September 5, 2011

Record last verified: 2011-09

Locations

NO (1)