Status:
COMPLETED
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
Lead Sponsor:
Meditrina Pharmaceuticals
Conditions:
Menstruation Disorders
Eligibility:
FEMALE
25-45 years
Phase:
PHASE2
Brief Summary
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the producti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00467493
Start Date
March 1 2007
End Date
September 1 2007
Last Update
June 3 2009
Active Locations (2)
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1
Jasper Research Clinic
Kalamazoo, Michigan, United States, 49007
2
University Women's Care
Southfield, Michigan, United States, 48034