search
Back to results

Soy Estrogen Alternative Study (SEA)

Primary Purpose

Cardiovascular Diseases, Endometrial Hyperplasia, Heart Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
estrogens, conjugated
diet, soy proteins
dietary supplements
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Perimenopausal/menopausal women, ages 45 to 55.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00000612
    Brief Title
    Soy Estrogen Alternative Study (SEA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Endometrial Hyperplasia, Heart Diseases, Menopausal Complaints, Uterine Diseases, Menopause

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    estrogens, conjugated
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, soy proteins
    Intervention Type
    Behavioral
    Intervention Name(s)
    dietary supplements

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Perimenopausal/menopausal women, ages 45 to 55.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9492349
    Citation
    Clarkson TB, Anthony MS, Williams JK, Honore EK, Cline JM. The potential of soybean phytoestrogens for postmenopausal hormone replacement therapy. Proc Soc Exp Biol Med. 1998 Mar;217(3):365-8. doi: 10.3181/00379727-217-44246.
    Results Reference
    background

    Learn more about this trial

    Soy Estrogen Alternative Study (SEA)

    We'll reach out to this number within 24 hrs