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

Trial Summary

This study was performed to determine the effect of oral vs. transdermal telapristone treatment during their pre-surgical window women who were scheduled for unilateral or bilateral mastectomies. 65 volunteers were able to complete the trial with 61 being fully compliant.

Telapristone was administered to the volunteers in a dose of 24mg gel or 12mg capsule every day for 4 weeks to determine the more effective treatment.

The study concluded that plasma concentrations of telapristone were much lower in the transdermal arm. In addition, the transdermal therapy was well received by the participants and was sufficiently well tolerated over the trial to be a viable prevention drug, if efficacious.


Randomized trial with two arms:

  • Arms:
    • Arm I: Telapristone gel (12 mg per breast, total 24 mg) and placebo capsule (12 mg) daily for 4 weeks.
    • Arm II: Placebo gel (12 mg per breast, total 24 mg) and telapristone capsule (12 mg) daily for 4 weeks.

Study Eligibility:
Ages Eligible for Study:18+ Years
Sexes Eligible for Study:Female
Accepts Healthy Volunteers:Yes
Inclusion and Exclusion Criteria:(see "Eligibility" tab)