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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467493
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : June 3, 2009
Information provided by:
Meditrina Pharmaceuticals

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 production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.

Condition or disease Intervention/treatment Phase
Menstruation Disorders Drug: Anastrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation
Drug Information available for: Anastrozole

Arm Intervention/treatment
Experimental: Anastrozole - A
Treatment for 26 consecutive days
Drug: Anastrozole
Experimental: Anastrozole -B
Treatment for 7 consecutive days early in menstrual cycle
Drug: Anastrozole
Experimental: Anastrozoe - C
Treatment for 7 consecutive days mid follicular phase
Drug: Anastrozole
Experimental: Anastrozole - D
Treatment for 7 consecutive days - mid cycle
Drug: Anastrozole
Experimental: Anastrozole - E
Treatment for 7 consecutive days - luteal
Drug: Anastrozole
Placebo Comparator: Anastrozole - F
Treatment with placebo for 26 consecutive days
Drug: Anastrozole

Primary Outcome Measures :
  1. Endometrial thickness as measured by transvaginal ultrasound, safety [ Time Frame: Over one menstrual cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00467493

United States, Michigan
Jasper Research Clinic
Kalamazoo, Michigan, United States, 49007
University Women's Care
Southfield, Michigan, United States, 48034
Sponsors and Collaborators
Meditrina Pharmaceuticals Identifier: NCT00467493     History of Changes
Other Study ID Numbers: M-001
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs