Research Article

Subcutaneously administered Menopur®, a new highly purified human menopausal gonadotropin, 
causes significantly fewer injection site reactions than Repronex® in subjects undergoing in vitro fertilization
William R Keye¹ , Bobby Webster² , Richard Dickey³ , Stephen Somkuti⁴ , Jack Crain⁵ and M Joseph Scobey^6 
1William Beaumont Hospital, In Vitro Fertility Clinic, Royal Oak, Michigan, USA
²Woman's Center for Fertility, Baton Rouge, Louisiana, USA
³Fertility Institute of New Orleans, New Orleans, Louisiana, USA
⁴Abington Reproductive Medicine, Abington, Pennsylvania, USA
⁵Reproductive Endocrine Associates of Charlotte, Charlotte, North Carolina, USA
⁶Ferring Pharmaceuticals Inc., Suffern, New York, USA

Abstract:

Background
The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur®] was compared with a currently available hMG [Repronex®] 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® (n = 61) or Repronex® 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® group reported injection site reactions (P < 0.001) compared to the Repronex® group. Overall, there was no statistically significant difference in the incidence of AEs between the two treatment groups.

Conclusion
Menopur® SC offers a greater safety and tolerability profile compared to Repronex® SC.


continue to article >>

Reproductive Biology and Endocrinology 2005 published by BioMed Central
An Open Access Research article
Published 9 November 2005
© 2005 Keye et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.