NCT00427531

Brief Summary

RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary. PURPOSE: This clinical trial is studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

January 25, 2007

Last Update Submit

March 16, 2011

Conditions

Hot Flashes

Keywords

hot flashes

Outcome Measures

Primary Outcomes (2)

  • Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary

  • Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period

Interventions

physiologic testingOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of bothersome hot flashes, defined by their occurrence ≥ 4 times/day * Daily hot flashes that have been present for ≥ 1 month PATIENT CHARACTERISTICS: * Female * Postmenopausal * ECOG performance status 0-1 * No history of allergic or other adverse reactions to adhesives * No other medical condition known to cause sweating and/or flushing * No implanted pacemakers or metal implants * No reliance on electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors) PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra L. Barton, R.N., Ph.D.

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

June 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

US(1)