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

This study is currently recruiting participants.

Verified by Meditrina Pharmaceuticals, April 2007

Sponsored by:	Meditrina Pharmaceuticals
Information provided by:	Meditrina Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00467493

Purpose

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	Intervention	Phase
Menstruation Disorders	Drug: Anastrozole	Phase II

MedlinePlus related topics: Menstruation

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Meditrina Pharmaceuticals:

Primary Outcome Measures:

Endometrial thickness as measured by transvaginal ultrasound, safety [ Time Frame: Over one menstrual cycle ]

Estimated Enrollment:	68
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467493

Locations

United States, Michigan
Jasper Research Clinic	Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Luann Leverette, LPN 800-458-6072 LuannLeverette@jasperclinic.biz
Principal Investigator: Thomas Blok, MD
University Women's Care	Recruiting
Southfield, Michigan, United States, 48034
Contact: Karen Collins 313-745-7885 kcollins@med.wayne.edu
Principal Investigator: Michael P Diamond, MD

Sponsors and Collaborators

Meditrina Pharmaceuticals

More Information

Study ID Numbers:	M-001
Study First Received:	April 27, 2007
Last Updated:	April 27, 2007
ClinicalTrials.gov Identifier:	NCT00467493
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anastrozole
Menstruation Disturbances
Healthy

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009