Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

University of Southern California82 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Oral Contraceptive

Interventions

Oral Contraceptive: Ortho-Novum® 1/35DRUG

Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.

Oral Contraceptive: Ovcon® 35DRUG

Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.

Oral Contraceptive: Microgestin Fe® 1/20DRUG

Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USC University Hospital

Los Angeles, California, United States

Outcomes

Primary Outcomes

Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups

Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells

Time frame: Up to 3 months.

Data from ClinicalTrials.gov

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