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Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women

NCT00084344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-05-30

No results posted yet for this study

Summary

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the body) may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen. This may improve quality of life and the ability to detect breast cancer with screening mammography.

PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.

Conditions

Interventions

DRUG

4-hydroxytamoxifen

PROCEDURE

breast imaging study

PROCEDURE

radiomammography

Sponsors & Collaborators

Principal Investigators

  • Seema A. Khan, MD · Robert H. Lurie Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-07-31
Completion
2004-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00084344 on ClinicalTrials.gov