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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00467493
Eligibility Criteria:
Inclusion Criteria:
* Between the ages of 25 and 45 and pre-menopausal;
* Non-lactating and not pregnant
* able to follow the schedule of procedures
* able to freely provide informed consent
* have clinically acceptable physical examination and safety laboratory studies
Exclusion Criteria:
* current use of any form of systemic contraceptive
* have self-reported irregular menstrual cycles
* intercurrent illness(es) detected on the screening physical
* unwilling or unable to use barrier methods of contraception
* have evidence of endometrial polyps or myomata on TVU/SIS that would interfere with endometrial thickness measurement
* detection of ovarian cyst(s) during adnexal examination on screening TVU/SIS measuring greater than 5 cm
* have history of, or current cancer, on any form exclusive of basal cell carcinoma
* BMI \>= 35
* history of alcohol or drug abuse in the past 5 years
* unwilling or unable to undergo study procedures within the necessary time frames
* history or current liver abnormalities as defined by ALT or AST \> 2X ULN
* treated or untreated diabetes defined as fasting blood sugar \>= 126 mg/dL
* untreated hypertension
* impaired renal function by estimated creatinine clearance \< 80mL/min
* have estradiol levels \< 20 pg/ml and FSH levels \> 40 mIU/mL or
* have a history of adverse reaction any aromatase inhibitor
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT00467493
Study Brief:
Protocol Section:
NCT00467493