Research Investigation of Soy and Estrogen

Completed · Phase 2 · Has a placebo group

Conditions studied: Menopause, Hot Flashes

In brief

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.

Key facts

Study ID

NCT00997893

Run by

University of Illinois at Chicago

People needed

96

Starts

2009-12-01

Expected to finish

2015-05-01

Last updated by the study team

2020-12-07

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.