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

Menstruation Disorders Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467493
• Other study ID #: M-001
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: June 2, 2009
• Start date: March 2007
• Est. completion date: September 2007

Study information

• Verified date: June 2009
• Source: Meditrina Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Menstruation Disorders
• Menstruation Disturbances

Intervention

Drug:
• Anastrozole

Locations

Country	Name	City	State
United States	Jasper Research Clinic	Kalamazoo	Michigan
United States	University Women's Care	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Meditrina Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness as measured by transvaginal ultrasound, safety		Over one menstrual cycle	No