The purpose of this study is to examine the effects of soy (NovaSoy®) and estrogen on
menopausal symptoms such as hot flashes, sleep disturbances, and mood alteration in
perimenopausal women.
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)
- > 7 self-reported hot flashes 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 > 33 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
- 3MS score <72 for women with eight years of education or less and <76 for women with
at least 9 years of education.
