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NCT03642119 · ClinicalTrials.gov registry record

Validation of an Objective Instrument to Measure Hot Flashes During Menopause

A clinical trial, sponsored by Pennington Biomedical Research Center.

Terminated
Registry status
12
Enrollment target

NCT03642119: Clinical Trial study, sponsored by Pennington Biomedical Research Center.

NCT03642119 is a clinical trial that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03642119 was terminated before completion, sponsored by Pennington Biomedical Research Center.

TERMINATED
Registry status
12 participants
Enrollment target

Study Summary

The overarching aim of this study is to assess the validity of the iButton®, a dual temperature and humidity sensing device (DS1923; Maxim IntegratedTM), as an objective method to assess hot flash incidence and dynamics in both a real world (ambulatory) and controlled (laboratory) setting. This study will test the overarching hypothesis that both self-report hot flashes in both an ambulatory and laboratory setting will correlate (confirm) the temperature and humidity sensing observed via the iButton® technology.

Primary Outcome

Skin temperatures will be continually monitored at 2 sites: the sternum (chest) and forearm, using iButton® technology during a single hot flash that is stimulated at the laboratory visit.

Interventions

  • DEVICE iButton®

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2018-09-07
Est. Completion 2022-09-19

Why NCT03642119 stopped before completion

NCT03642119 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which iButton® is the first listed.

NCT03642119 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03642119 about?

NCT03642119 is a clinical study titled "Validation of an Objective Instrument to Measure Hot Flashes During Menopause". The overarching aim of this study is to assess the validity of the iButton®, a dual temperature and humidity sensing device (DS1923; Maxim IntegratedTM), as an objective method to assess hot flash incidence and dynamics in both a real world (ambulatory) and controlled (laboratory) setting. This stud...

What is the current status of trial NCT03642119?

This trial is currently terminated. The enrollment target is 12 participants. The study started on 2018-09-07. Estimated completion is 2022-09-19.

What interventions are being tested in trial NCT03642119?

The interventions under investigation include: iButton® (DEVICE).

Who is sponsoring clinical trial NCT03642119?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03642119, the US trial registry maintained by the National Library of Medicine. NCT03642119 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.