Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Overview

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.

Full Title of Study: “Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2008

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Ortho-Novum® 1/35
    • Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
  • Active Comparator: Ovcon Fe®
    • Ovcon Fe® is an oral contraceptive that contains less progestin.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 34 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Southern California
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • DeShawn Taylor, M.D., Principal Investigator, University of Southern California

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