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Trial NCT00000612

Resource URI: http://static.linkedct.org/resource/trials/NCT00000612
linkedct:brief_title Soy Estrogen Alternative Study (SEA)
linkedct:condition <http://static.linkedct.org/resource/condition/13580>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/4397>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/7945>
linkedct:condition <http://static.linkedct.org/resource/condition/7949>
linkedct:criteria Perimenopausal/menopausal women, ages 45 to 55.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 55 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date December 1998
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000612
rdfs:label Trial NCT00000612
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000612
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 115
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000612>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/53916>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date January 1996
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2000