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Project Title Effects of Depo Provera on Breast Tissue Study

Researcher Karine Chung, MD, University of Southern California, Los Angeles, CA

Study Summary The purpose of this study is to gain a better understanding of the effects of Depo Provera, which contains a high dose of a synthetic progestin, on the breast tissue.

Who Can Participate? You can join the Effects of Depo Provera on Breast Tissue Study if you match ALL of these MAIN categories:

• You are currently receiving or are starting intra-muscular injections of Depo Provera

• You are a woman between the ages of 18 and 39

• You are pre-menopausal

• You have NO history of ANY cancer, including breast cancer and DCIS. Cancer of the skin is OK (squamous or basal cell carcinoma)

• You have NO history of breast abnormalities and have never had a breast biopsy

• You are NOT pregnant and have NOT been pregnant within the last six months

• You do NOT intend to get pregnant in the next several months

• You have NOT been breastfeeding or lactating within the last six months

• You are willing and able to refrain from taking aspirin or other non-steroidal anti-inflammatory drugs, like ibuprofen, Advil, Motrin, and Aleve during the study (because of their blood-thinning quality)

• You live near or are willing to travel (at your own expense) to the USC Health Sciences Campus Medical Center in Los Angeles

The researcher will ask you additional questions to be sure that this study is a right fit for you.

What Does Participation Involve? If you agree to participate in the Effects of Depo Provera on Breast Tissue Study, you will first be asked to provide two things: documentation of the date of your last Depo Provera shot and documentation of a normal breast examination by your primary care physician within the last six months.

You will then be asked to visit the University of Southern California Health Sciences Campus in Los Angeles, where you will be asked to fill out a questionnaire about your periods, pregnancy history, and hormonal contraceptive use (birth control pills, injections, or implants). You will also have a small amount of blood drawn (approximately 1 tablespoon) from a vein in your arm, for blood clot testing.

Once you have had two or more Depo Provera shots in a row you will be scheduled for a second study visit. This visit will occur 7, 14, OR 21 days after your second Depo Provera shot (if you have received more than two shots, it will be after your most recent shot).

At the beginning of your second visit, you will have a small amount of blood drawn (approximately 3 tablespoons) from a vein in your arm. Next, you will have a core breast biopsy. This routine procedure uses a device—similar to the one used to pierce ears—to take some samples of your breast tissue. It is done in the clinic with local anesthesia.

The researchers need to enroll 4 more women in this study.

Where? University of Southern California