FindTrial
Sign In

The Effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, and bone mineral density in ageing men with an age-related decline of testosterone.

The Effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, and bone mineral density in ageing men with an age-related decline of testosterone.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21427
Enrollment
240
Registered
2004-12-14
Start date
2004-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Four capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Men with testosterone level below the 50th percentile cut-of point (study population-based testosterone distribution) and age > 60 years.

Exclusion criteria

Exclusion criteria: 1. Severe diseases or conditions interfering with conduct of study; 2. Conditions for which increase of androgen-like substances are contra-indicated; 3. Symptomatic prostate hypertrophy, serious renal and liver function disturbances, heart failure, prostate- or breast cancer; 4. Diabetes mellitus de novo or already treated. A fasting capillary glucose level of 6.9 mmol/l or higher; 5. Diseases of adrenal gland, hypothalamo-pituitary-adrenal or -gonadal axis; 6. Use of steroids or androgens 6 months before study.

Design outcomes

Primary

MeasureTime frame
Functional Mobility and Quality of Life.—

Secondary

MeasureTime frame
Body Composition, Cognitive Function, Aortic Stiffness and Cardiovascular Risk Factors, Bone Mineral Density and Safety (Prostate, Liver Enzymes and Haematological Parameters).—

Contacts

Public ContactMarielle H. Emmelot-Vonk

University Medical Center Utrecht (UMCU), Julius Centrum, P.O. Box 85500

m.h.emmelotvonk@azu.nl+31 (0)30 2509291

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)