A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation

Phase 4 Completed 185 enrolled EMD Serono

RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.

Timeline

Start: 2003-09
Primary completion: 2004-05
Completion: 2004-05

Publications

Background Wilcox J, Potter D, Moore M, Ferrande L, Kelly E; CAP IV Investigator Group. Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies. Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Antagon	Unknown	0.25 mg	Subcutaneous
Subject	Cetrorelix	Other / unclassified	3 mg	Subcutaneous
Background	Human Menopausal Gonadotropin (hMG)	Protein / enzyme biologic	75 iu	Subcutaneous
Background	Recombinant Human Choriogonadotropin (r-hCG)	Protein / enzyme biologic	250 ug	Subcutaneous
Background	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	75 iu	Subcutaneous
Background	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	225 iu	Subcutaneous
Background	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	450 iu	Subcutaneous

Indications

No indication recorded.