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

• Main Authors: Somkuti Stephen (Author), Dickey Richard (Author), Webster Bobby (Author), Keye William R (Author), Crain Jack (Author), Scobey M Joseph (Author)
• Format: Book
• Published: BMC, 2005-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<p>Abstract</p> <p>Background</p> <p>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).</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>Menopur (R) SC offers a greater safety and tolerability profile compared to Repronex (R) SC.</p>

Item Description

10.1186/1477-7827-3-62
1477-7827