NCT00000601

Brief Summary

To determine if estrogen therapy in postmenopausal women with unstable angina reduces the incidence of ischemic episodes.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1995

Longer than P75 for phase_3

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

July 1, 1995

Completed
4.3 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
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2005

First QC Date

October 27, 1999

Last Update Submit

February 17, 2016

Conditions

Angina, UnstableCardiovascular DiseasesCoronary DiseaseHeart DiseasesPostmenopause

Interventions

estrogen replacement therapyDRUG
estrogensDRUG
progesteroneDRUG
hormone replacement therapyDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Postmenopausal women with unstable angina.

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

Sponsors & Collaborators

Related Publications (2)

  • Schulman SP, Thiemann DR, Ouyang P, Chandra NC, Schulman DS, Reis SE, Terrin M, Forman S, de Albuquerque CP, Bahr RD, Townsend SN, Cosgriff R, Gerstenblith G. Effects of acute hormone therapy on recurrent ischemia in postmenopausal women with unstable angina. J Am Coll Cardiol. 2002 Jan 16;39(2):231-7. doi: 10.1016/s0735-1097(01)01724-7.

    PMID: 11788212BACKGROUND

  • Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Gregory CA, Pekow PS. What is the best perfusion temperature for coronary revascularization? J Thorac Cardiovasc Surg. 1996 Dec;112(6):1622-32; discussion 1632-3. doi: 10.1016/S0022-5223(96)70021-1.

    PMID: 8975854BACKGROUND

MeSH Terms

Conditions

Angina, UnstableCardiovascular DiseasesCoronary DiseaseHeart Diseases

Interventions

Estrogen Replacement TherapyEstrogensProgesteroneHormone Replacement Therapy

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesProgesterone CongenersGonadal Steroid Hormones

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

July 1, 1995

Study Completion

June 1, 2000

Last Updated

February 18, 2016

Record last verified: 2005-02