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NOT YET RECRUITING

NCT07512323

PHASE2

Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

Sponsor: Rune Skovgaard Rasmussen

View on ClinicalTrials.gov

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.

Official title: Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study

Key Details

Gender

MALE

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2030-09-30

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Frail Elderly Patients Hypogonadal Males Testosterone Replacement Therapy Falls (Accidents) in Old Age

Interventions

DRUG

Nebido (Testosterone Undecanoate)

Testosterone supplementation is given intramuscularly with 1000 mg testosterone undecanoate, which has an effect for approx. 12 weeks, but which can be repeated more frequently between the 1st and 2nd administration. The injection is thus repeated in week 6. 3 injections per trial subject are expected, i.e., in weeks 1, 6, and 16. If the participants are motivated to continue so that long-term effects can be measured, the participants will be asked in week 12 whether they wish to continue to week 52. Upon acceptance of continuation to week 52, testosterone and placebo injections are offered according to original groups in weeks 26, 36, and 46, after which testing of primary and secondary endpoints is not only performed in week 20 but also in week 52.

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 or objective findings. Serum testosterone \< 10 nmol/L (16) 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 diseases (cirrhosis, AIDS, chronic renal failure). Primary testosterone deficiency in the form of testicular dysgenesis, Klinefelter syndrome (47,XXY), 46,XX males, LH resistance, Y chromosome deletions, other sex chromosome abnormalities. Significant abuse, mental illness, dementia, physical handicaps with inability to complete the intervention or tests, or to give informed consent. Contraindications for testosterone undecanoate are thus included in exclusion criteria, such as the presence of liver tumors, breast carcinoma, and prostate cancer, for which trial participants will be examined before the start of the trial.

Locations (1)

Holbæk Hospital

Holbæk, Denmark