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Soy Estrogen Alternative Study (SEA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000612
First Posted: October 28, 1999
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
October 27, 1999
October 28, 1999
May 13, 2016
January 1996
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Complete list of historical versions of study NCT00000612 on ClinicalTrials.gov Archive Site
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Soy Estrogen Alternative Study (SEA)
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Endometrial Hyperplasia
  • Heart Diseases
  • Menopausal Complaints
  • Uterine Diseases
  • Menopause
  • Drug: estrogens, conjugated
  • Behavioral: diet, soy proteins
  • Behavioral: dietary supplements
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Clarkson TB, Anthony MS, Williams JK, Honoré EK, Cline JM. The potential of soybean phytoestrogens for postmenopausal hormone replacement therapy. Proc Soc Exp Biol Med. 1998 Mar;217(3):365-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 1998
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Perimenopausal/menopausal women, ages 45 to 55.
Sexes Eligible for Study: Female
45 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000612
115
P01HL045666 ( U.S. NIH Grant/Contract )
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National Heart, Lung, and Blood Institute (NHLBI)
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National Heart, Lung, and Blood Institute (NHLBI)
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP