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NCT02679274 · ClinicalTrials.gov registry record · Early Phase 1
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
A Early Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT02679274 is a Early Phase 1 study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 3 participants.
The verdict
NCT02679274, a Early Phase 1 study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated that cycled administration of testosterone improves muscle mass and strength in healthy adults. It is proposed that cycled testosterone administration may be an effective adjuvant therapy for frail older men and women during rehabilitation programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC) rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled study, the investigators will test the effects of cycled testosterone administration (2 week on treatment, 2 weeks off treatment) on body composition and physical function in male and female nursing home residents undergoing rehabilitative care. Primary outcomes will be assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip dynamometers, short physical performance battery (SPPB), and quality of life (QOL) questionnaires. Data from this pilot project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.
Interventions
- DRUG Placebo
- DRUG Testosterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-02-16 |
| Est. Completion | 2016-09-20 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02679274
The ClinicalTrials.gov registry entry for NCT02679274 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02679274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02679274 about?
NCT02679274 is a clinical study titled "Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents". Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated...
What is the current status of trial NCT02679274?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2016-02-16. Estimated completion is 2016-09-20.
What interventions are being tested in trial NCT02679274?
The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG).
Who is sponsoring clinical trial NCT02679274?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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