Soy Estrogen Alternative Study (SEA)

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation, and health related quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

The results of many studies indicate that estrogen replacement therapy (ERT) reduces the risk of coronary heart disease (CHD) in postmenopausal women. However, less than 9 percent of these women choose to take ERT because of unwanted side effects and concerns about increased risk of cancer associated with ERT. Therefore, alternative therapies are needed.

The isoflavonoids found in soy protein (specifically genistein) have many properties that may reduce the risk of coronary heart disease. These include favorable effects on plasma lipids and coronary artery vasomotion. Furthermore, genistein is a tyrosine kinase (TK) inhibitor with inhibitory effects on thrombin activity and TK receptor-linked mitogens that may be associated with atherogenesis and neointimal formation after angioplasty.

DESIGN NARRATIVE:

Randomized, double-blind, placebo-controlled. The women were randomized into one of three groups: placebo, conjugated equine estrogens, or soy supplementation. Primary endpoints were the impact on menopausal complaints such as hot flushes, mood lability, anxiety, sleep disturbances; effects on plasma lipids and lipoproteins, including lipoprotein (a); effects on vaginal bleeding and endometrial proliferation; changes in health-related quality of life. Secondary endpoints included: assessment of the impact of these interventions on the progression of carotid artery intimal medial wall thickening as assessed by B-mode ultrasonography; bone density and bone turnover; additional measures to monitor the compliance and safety of the intervention such as mammography, anticipated or known side effects of hormone replacement therapy, blood levels of genistein, and clinical outcomes such as hospitalizations, physician visits, and symptoms. The study ended in December, 1998.

The study was a subproject within a program project on coronary atherosclerosis in females, primarily monkeys. Dr. Thomas B. Clarkson was the P.I. The subproject dollars were estimated based on the CRISP dollars assigned to the study which were approximately 12 percent of the total program project dollars and were broken down as follows: FY 1996 - 219,254; FY 1997 - $217,000; FY 1998 - $221,000.

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

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Perimenopausal/menopausal women, ages 45 to 55.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Study Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

November 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115
  • P01HL045666 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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