No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Functional Mobility and Quality of Life.
Secondary outcome
Body Composition, Cognitive Function, Aortic Stiffness and Cardiovascular Risk Factors, Bone Mineral Density and Safety (Prostate, Liver Enzymes and Haematological Parameters).
Background summary
Serum testosterone levels decline gradually after the age of 50 year. This decline coincides with increasing sigh and symptoms of aging, including tiredness and lack of energy, diminished libido, erectily dysfunction, reduced muscle mass and strength, reduced bone density, depression and diminished well-being. Androgen replacement might have a beneficial influence on these organs and functions in the aging male. But there are only limited clinical data available on the effects of testosterone replacement in males with a age-related decline of testosterone. Moreover, the results of this data are conflicting, insignificant or the study design has been insufficient.
Therefore, we conducted this randomized, placebo-controlled trial to assess the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, bone mineral density and safety (prostate, liver enzymes, hematological parameters) in ageing men with an age-related decline of testosterone.
Study objective
The hypothesis is that testosterone supplementation improves functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, and bone mineral density compared to placebo.
Study design
N/A
Intervention
Four capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.
P.O. Box 85500
Marielle H. Emmelot-Vonk
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509291
m.h.emmelotvonk@azu.nl
P.O. Box 85500
Marielle H. Emmelot-Vonk
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509291
m.h.emmelotvonk@azu.nl
Inclusion criteria
Men with testosterone level below the 50th percentile cut-of point (study population-based testosterone distribution) and age > 60 years.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7 |
| NTR-old | NTR31 |
| Other | : 014-91-063 (NWO) |
| ISRCTN | ISRCTN23688581 |