Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

University of Southern California1 site in 1 country33 target enrollmentAugust 2007

ConditionsOral Contraceptive

DrugsOral Contraceptive: Ortho-Novum® 1/35 Oral Contraceptive: Ovcon Fe®

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Oral Contraceptive
Sponsor: University of Southern California
Enrollment: 33
Locations: 1
Primary Endpoint: Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

November 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Southern California

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Premenopausal.
•Currently taking or want to start oral contraceptives for contraception
•Non-smoker.
•Competent to give informed consent (as judged by the investigator).
•Provided written informed consent.
•Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).