Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age70+
SponsorRune Skovgaard Rasmussen

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nebido (Testosterone Undecanoate)

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rune Skovgaard Rasmussen

Lead sponsor

University Hospital, Gentofte, Copenhagen

Sponsor institution