Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

January 24, 2018 updated by: University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age 18-34.
  2. Premenopausal.
  3. Currently taking or want to start oral contraceptives for contraception
  4. Non-smoker.
  5. Competent to give informed consent (as judged by the investigator).
  6. Provided written informed consent.
  7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).

Exclusion Criteria:1.

  1. Abnormal breast examination.
  2. History or current therapeutic or prophylactic use of anticoagulants.
  3. Known bleeding disorder or history of unexplained bleeding or bruising.
  4. History of breast cancer or previous diagnostic breast biopsy.
  5. Known allergy to local anesthetic.
  6. Currently pregnant or pregnant within the previous 6 months.
  7. Having any standard contra-indication to being prescribed OCs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ortho-Novum® 1/35
Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
Drug: Oral Contraceptive: Ortho-Novum® 1/35
Active Comparator: Ovcon Fe®
Ovcon Fe® is an oral contraceptive that contains less progestin.
Drug: Oral Contraceptive: Ovcon Fe®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
Time Frame: 32 weeks
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: DeShawn Taylor, M.D., University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 4, 2009

First Posted (Estimate)

September 7, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-07-00269

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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