NCT00319566

Brief Summary

The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,430

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 1992

Longer than P75 for phase_3

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

July 1, 1992

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

April 27, 2006

Status Verified

January 1, 2002

First QC Date

April 27, 2006

Last Update Submit

April 27, 2006

Conditions

Coronary Heart Disease

Keywords

Coronary Heart DiseaseHormone replacement therapyEstrogenPostmenopausal women

Outcome Measures

Primary Outcomes (2)

  • Myocardial Infarction

  • CHD Death

Secondary Outcomes (14)

  • CABG, revascularization, angina

  • serum lipids

  • quality of life

  • compliance

  • incidence of uterine bleeding and endometrial hyperplasia

  • +9 more secondary outcomes

Interventions

Premarin .625 mg daily plus medroxyprogesterone 2.5 mg dailyDRUG

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<75 y.o.
  • uterus present
  • postmenopausal
  • evidence of CHD
  • signed consent

You may not qualify if:

  • MI, CABG, mechanical revascularization within 6 months
  • serum triglyceride \>300mg/dl
  • used hormone therapy or estrogen vaginal cream in past 3 months
  • history of DVT or pulmonary embolism
  • history of breast cancer or mammogram suggestive of cancer
  • history of endometrial cancer
  • abnormal uterine bleeding
  • pap smear abnormal
  • SGOT more than 1.2 times normal
  • Disease judged to be fatal within 4 yrs
  • alcoholism, drug abuse
  • NYHA Class IV congestive heart failure
  • uncontrolled hypertension
  • uncontrolled diabetes
  • participation in any other investigational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Estrogens, Conjugated (USP)Medroxyprogesterone

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Stephen Hulley

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

July 1, 1992

Study Completion

July 1, 2001

Last Updated

April 27, 2006

Record last verified: 2002-01

Locations

US(1)