Author:
Keye William R,Webster Bobby,Dickey Richard,Somkuti Stephen,Crain Jack,Scobey M Joseph
Abstract
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.
Conclusion
Menopur (R) SC offers a greater safety and tolerability profile compared to Repronex (R) SC.
Publisher
Springer Science and Business Media LLC
Subject
Developmental Biology,Endocrinology,Reproductive Medicine,Obstetrics and Gynecology
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