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Project Title Effects of Birth Control Pills on Breast Tissue

Researcher Anna Wu, PhD, Heather Macdonald, MD, Claire Templeman, MD, Linda Hovanessian-Larsen, MD, Michael Press, MD, Debra Howes, MD, Frank Stanczyk, PhD, Malcolm Pike, PhD, and C. Leigh Pearce, PhD, University of Southern California, Los Angeles, CA

Study Summary The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when women use oral contraceptives (birth control pills) that contain different levels of the hormones estrogen and progestin.

Who Can Participate? You can join the Effects of Birth Control Pills on Breast Tissue study if you match ALL of these MAIN categories:

• You are a woman between ages 18 and 35
• You are currently using or are willing to start using an oral contraceptive for birth control
• You are premenopausal
• You have NOT been diagnosed with breast cancer (any stage, including LCIS and DCIS)
• You are NOT pregnant and have NOT been pregnant within the last six months
• You have NOT been breastfeeding or lactating within the last six months
• You are a non-smoker
• You are able to read, write, and speak English OR Spanish
• You live near or are willing to travel to the USC Health Sciences Campus Medical Center in Los Angeles

After you RSVP, the research team will ask you additional questions to be sure that this study is a right fit for you.

What Does Participation Involve? If you sign up for the Effects of Birth Control Pills on Breast Tissue study:

• You will be contacted by phone to answer questions about your history of pregnancy and hormone use (oral contraceptives, hormone replacement therapy, etc.), health, and other lifestyle factors.

• If you meet the main criteria for the study, you will be asked to go to the clinic for Study Visit 1. This visit is to confirm that the study is a good fit for you and that you are eligible. At the visit you will be asked to:
o Provide urine for a pregnancy test
o Have a breast examination (or you may bring with you documentation from your doctor stating that you have had a normal breast examination within the previous 6 months)

• If you are eligible and choose to join the study, you will be provided with three 28-day cycle packs of one of three birth control pills being studied
o Which birth control pill you get will be decided at random (like pulling a number out of a hat)
o If you are currently taking a different birth control pill, you will be asked to switch to one of the three being studied
o You will begin taking the birth control pill at 8:00 am the morning after you receive it and you will be asked to take one pill every morning at 8:00 am until the day after your Study Visit 2
o You will be asked to have a blood draw to ensure normal blood clotting. This blood draw may occur as a separate visit between Visit 1 and Visit 2 or it may occur on the morning of Visit 2.

• Study Visit 2 will happen on day 17-21 of your 2nd or 3rd pack of birth control pills. At this visit you will be asked to:
o Have a small sample of blood collected from a vein in your arm (about 1 tablespoon)
o Have a core breast biopsy. This routine procedure involves inserting a needle into your breast and removing 10 very small pieces of breast tissue. It is done in the clinic with local anesthesia.
o Have a second small sample of blood collected from a vein in your arm (about 2 tablespoons)

Where? University of Southern California Health Sciences Campus, Los Angeles