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

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

Reference8 articles.

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3. Gemzell CA, Diczfalusy E, Tillinger G: Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958, 18: 1333-1348.

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