Safety and Efficacy of CDB-2914 for Emergency Contraception

Phase 3 Completed 1623 enrolled HRA Pharma

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Timeline

Start: 2006-11
Primary completion: 2008-04-08
Completion: 2009-06-05

Outcome

Met primary endpoint

paper These results satisfy the protocol-defined statistical criteria for success because the pregnancy rate was lower than both the estimated expected pregnancy rate and a predefined clinical irrelevance threshold. PMID 20093897 ↗

Publications

Results Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulipristal Acetate	Unknown	30 mg	—

Indications

No indication recorded.