A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

Phase 3 Completed 1509 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.

Timeline

Start: 2006-06-27
Primary completion: 2007-11-19
Completion: 2008-01-15

Outcome

Met primary endpoint

registry analysis (unspecified test); 150 µg Corifollitropin Alfa vs 200 IU recFSH; p = 0.001; Mean Difference (Final Values) 1.2 (95% CI 0.5 to 1.9) NCT00696800 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Corifollitropin alfa	Protein / enzyme biologic	150 ug	Subcutaneous
Subject	Follitropin beta	Protein / enzyme biologic	200 iu	Subcutaneous
Background	Ganirelix	Protein / enzyme biologic	0.25 mg	Subcutaneous
Background	Progesterone	Other / unclassified	50 mg	Other
Background	Progesterone	Other / unclassified	600 mg	Other
Background	hCG	Unknown	5000 iu	—
Background	hCG	Unknown	10000 iu	—

Indications

No indication recorded.