A Prospective, Single-blind Study to evaluate the Effects of Daily Ulipristal Acetate (UPA) 10 mg on Breast Epithelial Cell Proliferation in Reproductive Age Women
A study evaluating the effect of Ulipristal Acetate (UPA) on breast cell growth in reproductive aged women for breast cancer prevention.
Sponsor: NIH
Enrolling: Female Patients Only
Study Length: 4 Months
Clinic Visits: 23
IRB Number: AAAQ8498
U.S. Govt. ID: NCT02922127
Contact: Molly Morgan: 212-305-0947 / mjm2331@cumc.columbia.edu
Additional Study Information: The UPA Breast Study will investigate a medication called ulipristal acetate (UPA), which is currently used as an emergency contraceptive and as a treatment for fibroids. The study is designed to investigate 1) whether taking UPA daily can decrease breast cell proliferation compared to traditional combined oral contraceptive pills; and 2) whether MRI can replace biopsies in future research studies investigating breast proliferation, as substituting biopsies for MRI would make future studies easier for women to take part in. Study participation will last 4-5 months. The first month will consist of up to seven short study visits and end with a breast MRI and biopsy of one breast. The participant will then take UPA for three months. The participant will attend 12 visits during that time, culminating in a follow up Breast MRI and biopsy of the other breast. A brief study discontinuation visit will occur two weeks later.
This study is closed
Investigator
Carolyn Westhoff, MD
Do You Qualify?
Are you a healthy woman aged 18-39? Yes No
Have you taken hormonal contraception, been pregnant or breast fed in the past 1 month? Yes No
Have you have previous breast surgery (including cosmetic)? Yes No
Are you able to come in for frequent (but short) study visits? Yes No
Have you been in another clinical trial investigating a new drug within the past 3 months? Yes No
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For more information, please contact:
Molly Morgan
mjm2331@cumc.columbia.edu
212-305-0947