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2001 MAY 24 - (NewsRx Network) -- Results of three studies evaluating Ferring Pharmaceuticals' highly purified, human-derived follicle stimulating hormone (hFSH) were presented at the 49th Annual Pacific Coast Reproductive Society Meeting and post-graduate course in Rancho Mirage, California.
This was the first public presentation of hFSH data from Phase III clinical trials. Ferring's hFSH was evaluated in two separate prospective, randomized, open-label, parallel-group, multicenter studies that compared hFSH delivered subcutaneously (SC) and intramuscularly (IM) to [Follistim.sup.R], a recombinant (genetically engineered) FSH administered SC.
One study tested oligoanovulatory patients undergoing ovulation induction, with an intent-to treat population of III the other study, testing patients undergoing in vitro fertilization (IVF), had an intent-to-treat population of 177. The primary measure of activity in the ovulation induction study was the percentage of patients achieving ovulation. Key secondary variables included peak mean serum E2 levels, the percentage of patients receiving human chorionic gonadotropin (hCG), and percentage achieving chemical, clinical and continuing pregnancy.
Results showed that Ferring's hFSH. administered SC and IM, was comparable to Follistim administered SC. In the IVF study, the primary ...