Skip to Main Content

An official website of the United States government

Government Funding Lapse

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit  cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at OPM.gov.

View 0 Studies Requested

Intra-mammary distribution of transdermal telapristone versus oral telapristone: a randomized window trial in women undergoing mastectomy

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.


Study Schema

The 1st step of the trial is a screening visit. Participants fill out consent, eligibility screening, and registration forms. Participants then have an optional 2nd screening visit to get research core biopsy of an unaffected breast. Next, participants go through randomization and are either given a placebo capsule and a Telapristone gel or a Telapristone capsule and a placebo gel. Both arms do daily treatments of both capsules and gels to both breasts for 4 weeks. During treatment participants get weekly phone calls for compliance and are supposed to fill out daily diary entries. At the end of treatment, participants have an adverse event assessment, mastectomy, and end of study treatment tests. One month later is the last follow up which covers adverse events that were unresolved at the post-intervention follow-up.