Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency (NCT07512323) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency
Denmark96 participantsStarted 2026-08-01
Plain-language summary
The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.
Who can participate
Age range70 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men aged 70 or over.
* Living at home in their own home or in sheltered housing.
* Independent walking function, possibly with a walking aid.
* Able to perform the chair-stand test a maximum of 8 times in 30 seconds or Timed Up and Go (TUG) of at least 30 seconds.
* There must be at least 3 symptoms of frailty or objective findings.
* Serum testosterone \< 10 nmol/L as an average of 2 independent measurements at the Center for Growth and Reproduction, Rigshospitalet.
Exclusion Criteria:
* Known or previous prostate cancer.
* Abnormally elevated serum PSA (PSA = prostate-specific antigen) corresponding to PSA \> 5 ng/ml or PSA \> 0.15 ng/ml/cc (relative to prostate size in cubic centimeters (cc)).
* Hemochromatosis.
* Heart diseases in the form of: Peri-, myo-, or endocarditis, angina pectoris, severe heart failure (NYHA class III and IV), severe hypertension (systolic BP \> 180 or diastolic BP \> 105 mmHg after possible antihypertensive treatment). - Resting dyspnea.
* Liver (ASAT \> 2 x upper normal limit) or renal insufficiency (serum creatinine \> 200 micromol/l).
* Severe intractable epilepsy or migraine.
* Insulin treatment.
* Previous or current bisphosphonate, fluoride, HRT, SERM, strontium, teriparatide, or more than 3 weeks of prednisolone treatment.
* Joint disease with acute inflammation.
* Active cancer disease, in chemo- or radiotherapy.
* Bone metabolic disease except for age-related osteoporosis.
* Autoimmune diseases, chronic systemic …