Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

Phase 2 Completed 35 enrolled HRA Pharma

RandomizedCrossoverDouble-blind

Summary

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle: * echographic follicle rupture * inhibition of follicle rupture * luteal phase progesterone levels * anovulatory progesterone levels

Timeline

Start: 2008-05
Primary completion: 2008-12
Completion: 2008-12

Publications

Results Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/deq157. Epub 2010 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ulipristal Acetate	Unknown	30 mg	Oral

Indications

No indication recorded.