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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00009659
Eligibility Criteria:
Participants must be female gender.
Participants age must be 45-70 years inclusive.
Participants FSH must be greater than 20 mlU/mL assay (this is a two-site immunofluorescent assay, Abbott Labs, post-menopausal range greater than 20).
Participants must have12 month or greater history of amenorrhea.
No current use of any sex steroid hormone replacement therapy (including selective estrogen receptor modulators) including transdermal, injectable, vaginal and oral preparations and willingness to abstain from such use during the study.
Participants BMI 19-30.
Participants must have a normal mammogram and pap smear at study entry.
Participants must be able and willing to maintain a minimum daily intake of 1000 mg calcium from dietary sources and/or supplements for the duration of the study.
Participants must have a normal pro-time and PTT at screening visit.
Participants must be able to read and speak English fluently so as to allow accurate self-administration of medication, recording of symptoms and unassisted completion of weekly questionnaire.
Participants must be in good health. Chronic medication use, except for glucocorticoid use or sex hormone replacement therapy, may be acceptable at the discretion of the principal investigator. Interval use of over-the-counter counter drugs, other than aspirin or NSAIDs, is acceptable but must be recorded.
Particippants hemoglobin must be greater than 10 g/dL.
Participants must be willing and able to self-administer daily medication, to complete self-administered questionnaires, to record daily symptoms and to return to the Clinical Center for weekly follow-up appointments for a minimum of 8 continuous weeks.
Participants with a history of diabetes mellitus type I or II are not eligible.
Participants with a history of malignancy within the past 5 years are not eligible.
Participants must not have a current use (within 90 days of study entry) of drugs that affect bone turnover and mineral metabolism such as bisphophonates, parathyroid hormone, hydrochlorothiazide and calcitonin.
Participants with triglyceride level of 500 mg/ml or greater at initial visit are not eligible.
Participants must not use cholesterol-lowering medication currently or within 6 weeks of study entry.
Participants with tobacco use currently or within 90 days of study entry are not eligible.
Participants with a history of diseases that alter mineral metabolism such as hyperparathyroidism, chronic renal insufficiency and hemodialysis are not eligible.
Participants requiring ongoing anti-inflammatory medication (e.g., aspirin, NSAIDs) whether prescribed or over the counter are not eligible.
Participants with current use of anticoagulants (e.g. Warfarin, heparin), anti-platelet drugs or history of bleeding disorder are not eligible.
Participants must not use OTC herbal or alternative treatments for hot flashes or other menopausal symptoms, such as DHEA, soy protein supplements, or other phytoestrogens within two months of study entry, and unwillingness to abstain from these products during the study.
Participants must not use drugs that affect the frequency of intensity of hot flashes such as clonidine or SSRI's within 2 months of study entry.
Participants must not have ischemic heart disease (e.g. angina, myocardial infarction or congestive heart failure).
Participants must not have significant abnormalities in the history, physical or laboratory examination.
Participants must not a history of venous thromboembolic events including deep vein thrombosis (DVT), pulmonary embolism, retinal vein thrombosis.
Participants must not a history of stroke, complicated migraine, documented transient ischemic attack or uncontrolled hypertension.
Participants must not absence of the uterus (hysterectomy).
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT00009659
Study Brief:
Protocol Section:
NCT00009659