MedTrace Logo

Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency

NCT07512323 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-06

No results posted yet for this study

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

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 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.

Sponsors & Collaborators

  • Rune Skovgaard Rasmussen

    lead OTHER

Principal Investigators

  • Mette Midttun, MD, DMSc · Holbaek Sygehus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-09-30
Completion
2030-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512323 on ClinicalTrials.gov