Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-26 @ 11:25 AM
Study NCT ID:
NCT00319566
Status:
COMPLETED
Last Update Posted:
2006-04-27
First Post:
2006-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart and Estrogen-Progestin Replacement Study (HERS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 2430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-07'}, 'statusVerifiedDate': '2002-01', 'completionDateStruct': {'date': '2001-07'}, 'lastUpdateSubmitDate': '2006-04-27', 'studyFirstSubmitDate': '2006-04-27', 'studyFirstSubmitQcDate': '2006-04-27', 'lastUpdatePostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Infarction'}, {'measure': 'CHD Death'}], 'secondaryOutcomes': [{'measure': 'CABG, revascularization, angina'}, {'measure': 'serum lipids'}, {'measure': 'quality of life'}, {'measure': 'compliance'}, {'measure': 'incidence of uterine bleeding and endometrial hyperplasia'}, {'measure': 'incidencet and severity of vasomotor and genitourinary symptoms'}, {'measure': 'adverse effects'}, {'measure': 'thromboembolic events'}, {'measure': 'symptomatic gallbladder disease'}, {'measure': 'fractures'}, {'measure': 'cancer'}, {'measure': 'stroke'}, {'measure': 'peripheral arterial disease'}, {'measure': 'total mortality'}]}, 'conditionsModule': {'keywords': ['Coronary Heart Disease', 'Hormone replacement therapy', 'Estrogen', 'Postmenopausal women'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<75 y.o.\n* uterus present\n* postmenopausal\n* evidence of CHD\n* signed consent\n\nExclusion Criteria:\n\n* MI, CABG, mechanical revascularization within 6 months\n* serum triglyceride \\>300mg/dl\n* used hormone therapy or estrogen vaginal cream in past 3 months\n* history of DVT or pulmonary embolism\n* history of breast cancer or mammogram suggestive of cancer\n* history of endometrial cancer\n* abnormal uterine bleeding\n* pap smear abnormal\n* SGOT more than 1.2 times normal\n* Disease judged to be fatal within 4 yrs\n* alcoholism, drug abuse\n* NYHA Class IV congestive heart failure\n* uncontrolled hypertension\n* uncontrolled diabetes\n* participation in any other investigational study'}, 'identificationModule': {'nctId': 'NCT00319566', 'briefTitle': 'Heart and Estrogen-Progestin Replacement Study (HERS)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Heart and Estrogen-Progestin Replacement Study (HERS)', 'orgStudyIdInfo': {'id': '713B-401-US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Stephen Hulley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}]}}}