💬In plain words
What the trial is, and whether it could suit you
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of dense breast tissue. One limitation to breast cancer screening with mammography is dense breast tissue, which decreases the sensitivity of screening as breast density masks cancer and precancerous lesions. Ulipristal acetate lowers the amount of progesterone made by the body which may temporarily decrease the density of the breast tissue, allowing for a more accurate mammogram for people with dense breast tissue.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Participant must provide written informed consent before any study-specific procedures or interventions are performed
* Ages 18-50 years. The maximum age cut off is due to the intervention only applying to premenopausal physiology only
* Assigned female at birth with at least one ovary in situ. Members of all races and ethnic groups will be included
* Presenting for a screening mammogram
* Has an antecedent mammogram within 24 months with a Breast Imaging Reporting and Data System (BI-RADS) breast composition score of Category C (heterogeneously dense) or D (extremely dense) for which images are available for analysis
* Report no history of breast cancer or symptoms concerning for breast cancer such as a self-palpated mass
* Reasonably assumed to be premenopausal by history of regular menses. For individuals who do not menstruate (due to hysterectomy or endometrial ablation), premenopausal status will be determined clinically by the absence of symptoms of menopause including weekly hot flashes which is consistent with clinical care
Exclusion Criteria:
* Having a mammogram as part of a diagnostic process
* Current breast implants in one or both breasts
* Pregnant, less than 1 year postpartum or breastfeeding within last 6 months at the time of their antecedent mammogram or their current mammogram. This exclusion is due to known changes in mammograms during pregnancy and postpartum that would preclude comparative analyses
* Using hormonal medications including estrogens or progestins
* History of allergy to UPA
* A history of liver disease (including but not limited to viral or autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis or Wilson's disease), alcoholism or a history of liver function tests such as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 3 x the upper limit of normal without known etiology
* Seeking pregnancy during study duration or a positive urine pregnancy for people at risk of pregnancy who cannot be reasonably assumed not to be pregnant at the beginning of the intervention
* Use of CYP3A4 inducer or inhibitors which may alter plasma concentrations of study drug (See Appendix A for list of common drugs/herbs). Regarding recent use of CYP3A4 inducers or inhibitors, a washout period will be deemed sufficient if at least 14 days or 5 half lives of the drug have elapsed prior to initiation of the study drug, whichever is longer. Participants will be advised to abstain from CYP3A4 inducers or inhibitors during the study and will only be ineligible if unable to
* Contraindication to MRI including: pacemakers, wires, stents, defibrillator, implanted hear values, aneurysm clips, metal pin, join, or prosthesis, electric devices (stimulator or pump), mental fragments, hearing aids, middle/inner ear prosthesis or dentures
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