Subcutaneously administered Menopur(R), a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex(R) in subjects undergoing in vitro fertilization

Abstract

Background: The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur(R)] was compared with a currently available hMG [Repronex (R)] in women undergoing in vitro fertilization (IVF). Methods: This was a randomized, open-label, parallel-group, multicenter study conducted in subjects undergoing IVF. Women (N=125), 18-39 years of age, underwent pituitary down-regulation with leuprolide acetate beginning 7 days prior to onset of menses and continuing up to the day before hCG administration. Subjects were randomized to receive subcutaneous (SC) Menopur (R) (n=61) or Repronex (R) SC (n=64) for a maximum of 12 days. All adverse events (AEs) were recorded and subject self-assessments of injection site reactions were recorded in a daily diary. Results: Significantly fewer subjects in the Menopur (R) group reported injection site reactions (P<0.001) compared to the Repronex (R) group. Overall, there was no statistically significant difference in the incidence of AEs between the two treatment groups. Conclusions: Menopur (R) SC offers a greater safety and tolerability profile compared to Repronex (R) SC. © 2005 Keye et al., licensee BioMed Central Ltd.