Research Investigation of Soy and Estrogen

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Medroxyprogesterone; Medroxyprogesterone Acetate; Phytoestrogens; Polyestradiol phosphate

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