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

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.

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Key information

Conditions

Menstruation Disorders Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Jasper Research Clinic, Kalamazoo, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

Primary outcomes

Endometrial thickness as measured by transvaginal ultrasound, safety

Time frame: Over one menstrual cycle

Sponsors and collaborators

Lead sponsor

Meditrina Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Apr 30, 2007
Registry last updated: Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed