Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

Phase 3 Completed 2221 enrolled HRA Pharma

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.

Timeline

Start: 2007-04
Primary completion: 2009-04
Completion: 2009-04

Outcome

Met primary endpoint

paper odds ratio [OR] 0.68, 95% CI 0.35-1.31. PMID 20116841 ↗

Publications

Results Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010 Feb 13;375(9714):555-62. doi: 10.1016/S0140-6736(10)60101-8. Epub 2010 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Levonorgestrel	Small molecule	1.5 mg	Oral
Subject	Ulipristal Acetate	Unknown	30 mg	Oral

Indications

No indication recorded.