Testosterone trial aims to reduce falls in frail seniors
NCT ID NCT07512323
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving testosterone to frail men aged 70 and older with low testosterone can improve their strength, balance, and mental well-being, and reduce their risk of falling. About 96 men who are too weak for strength training will receive either testosterone or a placebo for a period. The main goal is to see if they can stand up from a chair more times in 30 seconds, which is linked to lower fall risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
70 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Falls (accidents) in old age are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Holbæk Hospital
Holbæk, 4300, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a medication side effect score predict falls in older adults?
- Can a Dual-Task test predict falls in the elderly?
- Can a simple muscle exercise improve erectile function in men with low testosterone?
- New digital tool aims to connect frail seniors with needed services after hospital stay
- New implant could offer steady testosterone for men with low t
- Study probes link between common drugs and senior falls