Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

NCT07512323 | Not Yet Recruiting Phase 2

• 1 other identifier: H-16020521
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

hypogonadism; frailty; falls; testosterone replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

  At weeks 0, 4 and 20.

Secondary Outcomes (9)

• Measurement of fall frequency and severity

  At weeks 0, 4 and 20.

• Balance ability

  At weeks 0, 4 and 20.

• Avlund's mobility scale

  At weeks 0, 4 and 20.

• Geriatric Depression Scale (GDS)

  At weeks 0, 4 and 20.

• Montreal Cognitive Assessment (MoCA)

  At weeks 0, 4 and 20.

Study Arms (2)

Placebo

NO INTERVENTION

Patients receiving placebo

Intervention

ACTIVE COMPARATOR

Patients receiving testosterone undecanoate

Drug: Nebido (Testosterone Undecanoate)

Interventions

Nebido (Testosterone Undecanoate) DRUG

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.

Also known as: Intervention, Experimental

Intervention

Eligibility Criteria

• Age: 70 Years+
• Gender Eligibility Details: Inclusion Criteria: Men aged 70 or over.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rune Skovgaard Rasmussen: lead

Study Sites (1)

Holbæk Hospital

Holbæk, 4300, Denmark

Location

MeSH Terms

Conditions

Hypogonadism; Frailty

Interventions

testosterone undecanoate; Methods

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mette Midttun, MD, DMSc

  Holbaek Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rune S. Rasmussen, MSc, PhD

CONTACT

+4528757500; rsr@sund.ku.dk

Karsten Overgaard, MD, Neurologist

CONTACT

26172611; Karsten.Overgaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment with testosterone is made double-blind. We will ensure that the persons evaluating a patient do not have knowledge of the patient's treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc, PhD, associate professor of general pathology

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DK (1)