The purpose of this study is to learn how two different medications affect the breast: an estrogen-free selective progesterone-receptor modulator called UPA vs. a low-dose oral contraceptive pill. This is a randomized, phase I clinical trial. Participants have a 50% chance of receiving the UPA pill, and 50% chance of receiving the low-dose oral contraceptive.
If you sign up for the UPA Breast Health Study you will be contacted by the research team and asked to visit either Columbia University Medical Center or Weill Cornell Medical College for a screening visit. The study will last for about 4.5 months and will include 23 visits or fewer. Volunteers will be compensated for each study visit.
Participation includes three phases: screening, baseline, and treatment:
During your screening visit, you read an informed consent form. If you decide to participate, the research team will take your vitals and perform a brief physical exam, including an ultrasound. If you qualify for the study, you will be asked to return for a baseline cycle.
The baseline phase lasts approximately one month. You will have blood drawn 2-3 times per week in order to monitor your hormone levels. You do not take study-assigned pills during this phase. The research staff will collect blood and urine samples, and they will ask about any changes to your general health at these visits. Based on hormone levels, the researchers can determine a time period of heightened breast cell growth during your monthly cycle.
At end of this phase, the research team will perform an MRI of both breasts. A breast MRI uses a magnetic field and radio frequency pulses to produce detailed pictures of your breast. The MRI will last approximately 30-45 minutes.
The research team will also take a tissue sample (biopsy) from one of your breasts. The procedure will last about 20 minutes.
After your breast MRI and biopsy, you will be randomized (like the flip of a coin) to take one of the study medications.
You will take the study pill for about 77 days, with 11 visits during this time. You will go to the office every two weeks for the first two months and then twice a week during the third month. During these visits, the study staff will collect blood and urine samples and ask about any changes to your general health. Toward the end of the treatment phase, you will have a second breast MRI and a biopsy from the other breast. The research team will compare your MRI/biopsy results from before and after taking the study medication. From this, they can determine if the study drug did, in fact, influence breast cell growth.
Throughout the UPA Breast Health Study, the research team will be in close communication with you. You will receive daily text messages during the baseline and treatment phases of the study. These text messages will help ensure the program is working for you and serve as a daily reminder to take the study medication.
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