Frail Elderly PatientsPhase 2NCT07512323
Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency
A Phase 2 study testing Nebido (Testosterone Undecanoate) in people with Frail Elderly Patients and Hypogonadal Males, run by Rune Skovgaard Rasmussen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Frail Elderly Patients, Hypogonadal Males, Testosterone Replacement Therapy
- What is being tested?
- Nebido (Testosterone Undecanoate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2026to 30 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Holbæk Hospital
Holbæk, 4300
Mette Midttun, MD, DMSc, 45 - 20186174, memid@regionsjaelland.dk
About this study
Official title: Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study
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.
Read the detailed description
Please see the uploaded study protocol.
- Conditions
- Frail Elderly Patients, Hypogonadal Males, Testosterone Replacement Therapy, Falls (Accidents) in Old Age
- Being tested
- Nebido (Testosterone Undecanoate)
- Keywords
- hypogonadism, frailty, falls, testosterone replacement therapy
- Medical subject headings
- Hypogonadism, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebido (Testosterone Undecanoate)Drug
Also called Intervention, Experimental
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Patients receiving placebo |
| Intervention | Active comparator | Patients receiving testosterone undecanoate Receives: Drug: Nebido (Testosterone Undecanoate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chair-stand test
A measure of general strength in extremities. Number of times the participant can stand up and sit down from a chair in 30 seconds. A good correlation (r=0.78) has been found with leg press and acceptable test-retest reliability (ICC=0.86). It has recently been scientifically documented that the ability among elderly persons to perform this simple test correlates with the risk of serious fall accidents
Measured: At weeks 0, 4 and 20.
Secondary outcomes (9)
Measurement of fall frequency and severity
Registered via a questionnaire for each trial subject and is also included in the monitoring of adverse events.
Measured: At weeks 0, 4 and 20.
Balance ability
Tested via the Tandem test, which contains three starting positions: 1) Standing with feet together, standing in semi-tandem stance, and standing in tandem stance.
Measured: At weeks 0, 4 and 20.
Avlund's mobility scale
Questions about experiencing fatigue and need for support in common activities of daily living. Avlund's mobility scale is correlated with isometric muscle strength, simple functional tests, increased risk of hospitalizations, and mortality. Good inter- and intra-reliability (kappa 0.72-1.00) has been shown. Scores range from 0 to 6, and higher scores indicate worse outcome.
Measured: At weeks 0, 4 and 20.
Geriatric Depression Scale (GDS)
Questionnaire about depression and psychological well-being. Scores range from 0 til 15. Score below 5 are normal, while scores of 5 or higher indicate varying degrees of depression, scoring 13-15 indicates severe depression.
Measured: At weeks 0, 4 and 20.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a cognitive screening instrument which provides an estimate of the level of intellectual functioning. Scores are from 0 to 30, where a score of 26 or higher is considered normal. Montreal Cognitive Assessment is moreover sensitive to mild cognitive problems as well as dementia. Studies have shown that Montreal Cognitive Assessment is more sensitive than Mini Mental State Examination to detecting mild cognitive changes and is as effective in identifying the incidence of Alzheimer's disease.
Measured: At weeks 0, 4 and 20.
Mini Mental State Examination (MMSE)
Cognitive screening test that provides an estimate of the intellectual functional level. This test is included as it is performed as standard at the Geriatric Outpatient Clinic. Combined, MMSE and MoCA provide a broader assessment of cognitive functional level. Scores range from 0 to 30, higher scores indicate better cognitive status. Scores from 26 to 30 are considered normal.
Measured: At weeks 0, 4 and 20.
Quality of life EQ-5D
Questionnaire about perceived quality of life. Scores range from 0 to 1 (first scale) and from 0 to 100 (second scale). Higher scores indicate better quality of life.
Measured: At weeks 0, 4 and 20.
Clinical Frailty Scale (CFS)
General assessment of health and functional level in the elderly. Scoring ranges from 1 to 9, and higher scores indicate more frailty.
Measured: 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.
Assessment of fall risk in the elderly.
Measured: At weeks 0, 4 and 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized equally into 2 different treatment groups with 48 participants each: 1. A control group given 3 placebo injections 2. A testosterone group given 3 testosterone injections. Randomization is thus into two arms so that the effect of testosterone can be evaluated against placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rune Skovgaard Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen
- Investigators
- Mette Midttun, MD, DMSc, Principal investigator, Holbaek Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512323
- Sponsor's protocol ID
- H-16020521
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there is interest, we will consider sharing data.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study
- ClinicalTrials.gov ID
- NCT07512323
- Acronym / sponsor ID
- H-16020521
- Conditions
- Frail Elderly Patients, Hypogonadal Males, Testosterone Replacement Therapy, Falls (Accidents) in Old Age
- Keywords
- hypogonadism, frailty, falls, testosterone replacement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rune Skovgaard RasmussenUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized equally into 2 different treatment groups with 48 participants each: 1. A control group given 3 placebo injections 2. A testosterone group given 3 testosterone injections. Randomization is thus into two arms so that the effect of testosterone can be evaluated against placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Patients receiving placebo |
| Intervention | Active comparator | Drug: Nebido (Testosterone Undecanoate)Patients receiving testosterone undecanoate |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebido (Testosterone Undecanoate)Also: Intervention, ExperimentalTestosterone 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. | Drug | Intervention |
Primary outcome
Chair-stand test
Time frame: At weeks 0, 4 and 20.
A measure of general strength in extremities. Number of times the participant can stand up and sit down from a chair in 30 seconds. A good correlation (r=0.78) has been found with leg press and acceptable test-retest reliability (ICC=0.86). It has recently been scientifically documented that the ability among elderly persons to perform this simple test correlates with the risk of serious fall accidents
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. If there is interest, we will consider sharing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mette Midttun, MD, DMSc principal investigator
Holbaek Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nebido (Testosterone Undecanoate) in people with Frail Elderly Patients and Hypogonadal Males, run by Rune Skovgaard Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rune S. Rasmussen, MSc, PhD (+4528757500, rsr@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chair-stand test (time frame: At weeks 0, 4 and 20.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.