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NCT02069431 · ClinicalTrials.gov registry record · Phase 1
Oxytocin Aging Study
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT02069431: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT02069431 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02069431, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
The life expectancy of older Americans continues to increase, with persons aged \> 65 years representing the fastest growing segment of the US population (Manton et al., 1995). While prolongation of life remains an important public health goal, a goal of even greater significance is that extended life should involve preservation of the capacity to live independently and to function well physically, cognitively, and socioemotionally (Katz et al., 1983). Therefore, identification of proven interventions to maintaining functioning across these domains and prevent disability is a major public health challenge (Branch et al., 1991). Greater physical and cognitive independence in older adults has been shown to crucially influence social integration in old age (Cornwell \& Waite, 2009), resulting in significant increase in quality of life and reduction of risk for morbidity and mortality, social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A promising candidate to promote functional levels across physical, cognitive, and socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et al., 2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012). Combining neuroendocrine with behavioral approaches (e.g., performance-based measures of physical and cognitive function), the proposed multidisciplinary research therefore sets out to clarify the extent to which intranasal administration of OT over a period of 4 weeks can reduce inflammation and improve physical and cognitive function in older men. Constituting a complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this project will also allow examination of interactions between OT's effect on physical health, cognition, and socioemotional function.
Primary Outcome
The use of intranasal OT will reduce inflammatory biomarkers (IL-6, tumor necrosis factor (TNF)-α, TNF-sR1, TNF-sR2, CRP) measured in blood samples.
Interventions
- DRUG Intranasal Oxytocin spray
- OTHER Intranasal Placebo spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-05 |
| Phase | Phase 1 |
Why NCT02069431 stopped before completion
NCT02069431 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 2 interventions - of which Intranasal Oxytocin spray is the first listed.
NCT02069431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02069431 about?
NCT02069431 is a clinical study titled "Oxytocin Aging Study". The life expectancy of older Americans continues to increase, with persons aged \> 65 years representing the fastest growing segment of the US population (Manton et al., 1995). While prolongation of life remains an important public health goal, a goal of even greater significance is that extended li...
What is the current status of trial NCT02069431?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2016-02. Estimated completion is 2020-05.
What interventions are being tested in trial NCT02069431?
The interventions under investigation include: Intranasal Oxytocin spray (DRUG), Intranasal Placebo spray (OTHER).
Who is sponsoring clinical trial NCT02069431?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02069431's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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