Stroke and MI in Users of Estrogen/Progestogen

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005466
• Other study ID #: 4910
• Secondary ID: R01HL047043
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: February 17, 2016
• Start date: August 1991
• Est. completion date: July 1995

Study information

• Verified date: May 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To estimate the relative risks of acute myocardial infarction (MI) and of stroke in postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone.

Description:

BACKGROUND:

Post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart. However, because estrogen alone substantially increases the risk of endometrial cancer, estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen (E/P), a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone. In 1991, there were almost no data on the risk of cardiovascular disease in post-menopausal women who used E/P combinations.

DESIGN NARRATIVE:

The study had a case-control design, Cases were women hospitalized with MI or stroke in any of nine participating Northern California Kaiser Permanente hospitals in a 36 month period. For each case, one control, matched by year of birth, was selected at random from among members of the Kaiser Permanente Health Plan who were expected to use the same nine hospitals for their medical care. Information about use of estrogen, E/P combinations, past use of oral contraceptives, menopause, hysterectomy and oophorectomy, demographics, general health status, preventive health care, and cardiovascular risk factors were collected in interviews done of the subjects or, for fatal cases, a surrogate. Information about then current use of estrogen and E/P combinations were also gathered by reviewing medical records.

The investigators used conditional logistic regression analysis to estimate the relative risks of MI and of stroke in users of E/P combinations, taking into account prior oophorectomy and other potential confounders. They also estimated the risks of acute MI and of stroke in users of estrogen alone, accounting for prior oophorectomy and potential confounders.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1995
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Infarction
• Postmenopause
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Petitti DB, Sidney S, Quesenberry CP Jr, Bernstein A. Ischemic stroke and use of estrogen and estrogen/progestogen as hormone replacement therapy. Stroke. 1998 Jan;29(1):23-8. — View Citation

Sidney S, Petitti DB, Quesenberry CP Jr. Myocardial infarction and the use of estrogen and estrogen-progestogen in postmenopausal women. Ann Intern Med. 1997 Oct 1;127(7):501-8. — View Citation