Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00997893
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00997893
Study Brief:
Protocol Section:
NCT00997893