Know Cancer

or
forgot password

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)


Phase 2
25 Years
45 Years
Not Enrolling
Female
Menstruation Disorders

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Endometrial thickness as measured by transvaginal ultrasound, safety

Outcome Time Frame:

Over one menstrual cycle

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

M-001

NCT ID:

NCT00467493

Start Date:

March 2007

Completion Date:

September 2007

Related Keywords:

  • Menstruation Disorders
  • Menstruation Disturbances

Name

Location

Jasper Research ClinicKalamazoo, Michigan  49007
University Women's CareSouthfield, Michigan  48034