Oral Contraceptive (OC) Estrogen 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 estrogen (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 estrogen; this research will examine that in detail. This research will also test whether the results found in HS-07-00269 can be confirmed.

Full Title of Study: “The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?”

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: June 2015

Interventions

  • Drug: Oral Contraceptive: Ortho-Novum® 1/35
    • Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
  • Drug: Oral Contraceptive: Ovcon® 35
    • Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
  • Drug: Oral Contraceptive: Microgestin Fe® 1/20
    • Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

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® 35
    • Ovcon® 35 is an oral contraceptive that contains less progestin.
  • Active Comparator: Microgestin Fe® 1/20
    • is an oral contraceptive that contains less estrogen.

Clinical Trial Outcome Measures

Primary Measures

  • To measure breast cell proliferation levels between the three oral contraceptive dose groups.
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18-35 2. BMI <30 kg/m2 3. Premenopausal with regular cycles or currently taking an OC 4. Not currently or recently pregnant or nursing (within previous 6 months) 5. Non-smoker 6. No use of antibiotics within the prior 4 weeks 7. Competent to provide written informed consent (as judged by study team) 8. Willing to adhere to the OC regimen 9. Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure 10. Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure Exclusion Criteria:

1. Diabetes 2. Abnormal breast examination 3. Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians) 4. History or current therapeutic or prophylactic use of anticoagulants 5. Known bleeding disorder or history of unexplained bleeding or bruising 6. History of breast cancer or previous diagnostic breast biopsy 7. Known allergy to local anesthetic

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Southern California
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heather MacDonald, M.D., Principal Investigator, University of Southern California
  • Overall Contact(s)
    • Anna H Wu, Ph.D., 323 865 0484, annawu@usc.edu

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