Ganirelix

Background: Ganirelix is a synthetic decapeptide and a competitive gonadotropin-releasing hormone (GnRH) antagonist. Derived from endogenous GnRH, ganirelix has amino acid substitutions. Ganirelix is indicated for controlled ovarian hyperstimulation in assisted reproduction techniques. The first case of pregnancy achieved after the use of ganirelix in an assisted reproduction program was reported in 1998. Ganirelix was first approved by the FDA on July 29, 1999.

Indication: Ganirelix is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques (ART).

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

Interventions: Biological: RecFSH / Follitropin beta (Days 1 to 7)
Drug: Corifollitropin alfa
Drug: Placebo RecFSH / follitropin beta
Drug: Placebo Corifollitropin alfa
Biological: RecFSH / Follitropin beta (Days 8 to hCG)
Drug: Ganirelix
Biological: hCG
Biological: Progesterone