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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT00770159
Eligibility Criteria:
Inclusion Criteria:
* Subject is less than or equal to 75 years of age
* Subject is a postmenopausal female
* Subject is within 30% of ideal body weight
* Subject is judged to be in good health
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption for the duration of the study
* Subject is willing to avoid strenuous physical activity for the duration of the study
* Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study
Exclusion Criteria:
* Subject has a history of multiple/severe allergies to foods or drugs
* Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
* Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
* Subject has a history of bone disease or treatment with bisphosphonates
* Subject has an infection/condition that would suppress the immune system, including HIV
* Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
* Subject requires use of any prescription or non-prescription medications during the study
* Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00770159
Study Brief:
Protocol Section:
NCT00770159