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

NCT00467493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2009-06-03

No results posted yet for this study

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.

Conditions

  • Menstruation Disorders

Interventions

DRUG

Anastrozole

Sponsors & Collaborators

  • Meditrina Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467493 on ClinicalTrials.gov