Mammogram Pretreatment With Ulipristal Acetate

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorOHSU Knight Cancer Institute

About this trial

This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of extremely 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 extremely dense breast tissue.

Eligibility criteria

Qualifiers

Participant or legally authorized representative (LAR) 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Mammogram
  • Survey Administration
  • Ulipristal Acetate

Treatment groups

26 Participants
are divided into 1 treatment group

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator