The Effects of Long term testosterone supplementation In testosterone deficient men on Quality of life, Sarcopenia, cognitive function, Obesity and vasculaR ageing

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

ISRCTN

Registry ID

ISRCTN23688581

Enrollment

240

Registered

2005-05-16

Start date

2004-01-01

Completion date

Unknown

Last updated

2022-11-07

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

Conditions

Age-related decline of testosterone Urological and Genital Diseases Age-related decline of testosterone

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Men with testosterone level below the 50th percentile cut-off point (study population-based testosterone distribution) 2. Age more than 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 six months before study

Design outcomes

Primary

Measure	Time frame
Functional mobility and quality of life.	—

Secondary

Measure	Time frame
1. Body composition 2. Cognitive function 3. Aortic stiffness and cardiovascular risk factors 4. Bone mineral density and safety (prostate, liver enzymes and haematological parameters)	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026