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Research Investigation of Soy and Estrogen - NCT00997893-60612(Clinical Trial 370028)



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City:  Chicago
State:  
IL
Zip Code: 60612
Conditions: Menopause - Hot Flashes
Purpose: 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.
Study summary:
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 > 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
Study is available at: University of Illinois at Chicago
Chicago, IL 60612
United States

Primary Contact:
Mary Winters, BS
Email: UIC.RISE.study@gmail.com
Phone: 312-355-5652

Secondary Contact:
Mary Winters, BS
Email: UIC.RISE.study@gmail.com
Phone: 312-355-5652
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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