NCT00000605

Brief Summary

To determine if postmenopausal hormone replacement therapy in women following coronary bypass surgery would reduce the occurrence of graft occlusion and delay the development of graft atherosclerosis.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1996

Typical duration for phase_3 cardiovascular-diseases

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

August 1, 1996

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

February 18, 2016

Status Verified

April 1, 2005

First QC Date

October 27, 1999

Last Update Submit

February 17, 2016

Conditions

Cardiovascular DiseasesCoronary ArteriosclerosisCoronary DiseaseHeart DiseasesMyocardial IschemiaPostmenopause

Interventions

hormone replacement therapyDRUG
estrogensDRUG
medroxyprogesteroneDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Postmenopausal women who had undergone coronary artery bypass graft.

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

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

Hormone Replacement TherapyEstrogensMedroxyprogesterone

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pamela Ouyang

    Johns Hopkins University

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1996

Study Completion

July 1, 2002

Last Updated

February 18, 2016

Record last verified: 2005-04