Trial | NCT00319566  Report issue

Official Title

Heart and Estrogen-Progestin Replacement Study (HERS)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2430
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.
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
Study Started
Jul 31
1992
Study Completion
Jul 31
2001
Last Update
Apr 27
2006
Estimate

Drug Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted