Heart and Estrogen-Progestin Replacement Study (HERS)

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estrogens; Estrogens, Conjugated (USP); Medroxyprogesterone; Medroxyprogesterone Acetate; Progestins

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