Efficacy Trial of CDB 2914 for Emergency Contraception
Status:
Completed
Trial end date:
2001-09-01
Target enrollment:
Participant gender:
Summary
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new
antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of
CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Subjects are randomized to receive a one-time treatment with either one dose of 50 mg
CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with
follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days
after expected onset of menses (if needed)
The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency
postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)