Researchers at Columbia University need healthy women in the greater New York City area between the ages of 18 and 39 to participate in a study investigating the effects of two medications on breast cell proliferation. The new pill being studied contains Ulipristal Acetate, or UPA. UPA is a selective progesterone-receptor modulator, or SPRM. Like tamoxifen (a selective estrogen receptor modulator, or SERM), UPA interacts with female hormones that affect the breast. Previous studies show that progesterone increases breast cell growth, and UPA may block this increase. The control medication in this study is a low-dose birth control pill that has been used in the U.S. for over 30 years. The research team wants to see if the UPA pill has a different effect on breast cells than currently used low-dose contraceptive pills. Because SPRM’s hormonal interference can block ovulation, UPA is also a potential contraceptive. This research is the first step in learning if an UPA contraceptive could decrease the long-term risk of breast cancer.
The purpose of this phase I clinical trial 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 study completed recruitment for the low-dose oral contraceptive group. Now, the research team is looking for participants to enroll in the UPA group.
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.