Status:
COMPLETED
Research Investigation of Soy and Estrogen
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Menopause
Hot Flashes
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
Anxiety is a common, but understudied complaint in midlife women, and increases during the menopausal transition. Changes in estrogen are dramatic during the menopausal transition, and indirect data s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00997893
Start Date
December 1 2009
End Date
May 1 2015
Last Update
December 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612