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Not yet recruiting NCT07512323

Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nebido (Testosterone Undecanoate).
Who it may be relevant to
Registry conditions: Frail Elderly Patients, Hypogonadal Males, Testosterone Replacement Therapy, Falls (Accidents) in Old Age. Basic parameters: from 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Please see the uploaded study protocol.

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 we

Primary outcome measures

  • Chair-stand test [Time frame: At weeks 0, 4 and 20.]
Secondary outcome measures (9)
  • Measurement of fall frequency and severity [Time frame: At weeks 0, 4 and 20.]
  • Balance ability [Time frame: At weeks 0, 4 and 20.]
  • Avlund's mobility scale [Time frame: At weeks 0, 4 and 20.]
  • Geriatric Depression Scale (GDS) [Time frame: At weeks 0, 4 and 20.]
  • Montreal Cognitive Assessment (MoCA) [Time frame: At weeks 0, 4 and 20.]
  • Mini Mental State Examination (MMSE) [Time frame: At weeks 0, 4 and 20.]
  • Quality of life EQ-5D [Time frame: At weeks 0, 4 and 20.]
  • Clinical Frailty Scale (CFS) [Time frame: At weeks 0, 4 and 20.]
  • Falls Efficacy Scale - International (FES-I, Fear of falling). Scores range from 16 to 64, and higher scores indicate increased anxiety of having a severe fall accident. [Time frame: At weeks 0, 4 and 20.]

Eligibility criteria

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Holbæk Hospital — Holbæk

Identifiers

NCT: NCT07512323 · H-16020521

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗