Soy Estrogen Alternative Study (SEA)
Condition: Cardiovascular Diseases; Endometrial Hyperplasia; Heart Diseases; Menopausal Complaints; Uterine Diseases; Menopause
MeSH terms: Endometrial Hyperplasia; Uterine Diseases; Cardiovascular Diseases; Heart Diseases; Hyperplasia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): estrogens, conjugated; diet, soy proteins; dietary supplements
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Masking: Double
Primary purpose: Prevention