Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

University of Southern California33 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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Oral Contraceptive

Interventions

Oral Contraceptive: Ortho-Novum® 1/35DRUG

Oral Contraceptive: Ovcon Fe®DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Los Angeles County Hospital

Los Angeles, California, United States

Outcomes

Primary Outcomes

Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups

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

Time frame: 32 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.