NCT00580775

Brief Summary

As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

December 19, 2007

Last Update Submit

January 20, 2015

Conditions

Menopausal Women

Keywords

MenopauseHormone Replacement TherapySudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    48 Months

Secondary Outcomes (1)

  • Repolarization parameters

    48 Months

Study Arms (2)

Placebo

Observing heart rate variability in placebo and active estrogen preparations

Active estogen

Observing heart rate variability in placebo and active estrogen preparations

Eligibility Criteria

Age42 Years - 58 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.

You may qualify if:

  • participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180

You may not qualify if:

  • non-participants of parent study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine / Yale New Haven Hospital

New Haven, Connecticut, 208017, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rachel Lampert, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 27, 2007

Study Start

September 1, 2005

Primary Completion

July 1, 2008

Study Completion

December 1, 2010

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

US(1)