A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001)
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