Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers

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