Research Investigation of Soy and Estrogen
Condition: Menopause; Hot Flashes
MeSH terms: Hot Flashes
Intervention: Soy Phytoestrogen; Estradiol; Medroxyprogesterone Acetate (MPA); Soy Placebo; MPA Placebo
Intervention description: Novasoy® pill (55 mg); Estradiol pill (1 mg); medroxyprogesterone acetate (MPA) (10mg); oral placebo pill (0mg Soy Phytoestrogen); oral placebo pill (0mg MPA)
Intervention MeSH terms: Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Estradiol; Polyestradiol phosphate; Estrogens; Phytoestrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: menopause; hot flashes; soy; estrogen; anxiety

Summary:

      The purpose of this study is to determine the effects of oral estradiol and soy
      phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Perimenopausal as defined by the Stages of Reproductive Aging Workshop (STRAW)
             criteria, specifically in either of the two following stages: a) early transition
             defined as changes in cycle length of seven days or more in either direction in
             consecutive cycles or b) late transition defined as > 60 days amenorrhea and FSH > 40
             IU/mL

          -  Intact uterus/ovaries (i.e. no surgical menopause)

          -  at least 1 self-reported hot flash per week

          -  Estrogen therapy not contraindicated

          -  Able to give informed consent

          -  Age between 40 and 65 years

          -  English as first and primary language

        Exclusion Criteria:

          -  Positive pregnancy test or breastfeeding (pregnancy tests will be given to all women)

          -  Obesity > 35 BMI

          -  Previous history of endometrial hyperplasia/neoplasia

          -  Previous history of cancers of the breast or reproductive tract

          -  History of presence of myocardial infarction (MI) or stroke

          -  Current clinical diagnosis or a diagnosis within the past year of an anxiety disorder,
             severe recurrent depression, or severe psychiatric disturbance

          -  History of head injury with more than 60 minutes loss of consciousness

          -  History of neurological condition affecting cognitive function (e.g., brain tumor,
             multiple sclerosis)

          -  History of developmental disability affecting cognitive function (e.g., mental
             retardation, attention deficit)

          -  Current use of CNS-acting medication (e.g., antidepressants, anxiolytics,
             diphenhydramine)

          -  History or presence of cerebrovascular accident, sickle cell anemia

          -  History of alcohol or drug abuse as defined by DSM criteria

          -  Abnormal vaginal bleeding of undetermined cause

          -  Untreated or uncontrolled hypertension defined as systolic blood pressure greater than
             165 mm hg or diastolic blood pressure greater than 95 mm hg

          -  Concurrent administration of medication containing estrogen, progestin, SERM within
             four months of enrollment

          -  Concurrent administration of medication containing St. John's wort, bisphosphonates,
             or dietary phytoestrogens within one month of enrollment

          -  History of migraine associated with hormone use

          -  History or presence of deep vein thrombosis, thrombophlebitis or thromboembolic
             disorder

          -  Current participation in any other clinical trial within 30 days of enrollment

          -  Smoker

          -  Diabetes

          -  Premature ovarian failure (defined as having last menstrual period before age 40)

          -  Abnormal PAP smear in previous year

          -  Abnormal mammogram in previous year

          -  Vegans (vegetarians who tend to consume greater than average doses of phytoestrogens)

          -  Allergy to soy (affects ~1% of people in the United States; reactions are typically
             mild)

          -  Symptomatic fibroids (significant size or significant menstrual changes)

          -  Menorrhagia

          -  Lactose intolerant