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Journal List > Reprod Biol Endocrinol > v.3; 2005

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Reprod Biol Endocrinol. 2005; 3: 62.
Published online 2005 November 9. doi: 10.1186/1477-7827-3-62.
PMCID: PMC1309620
Copyright © 2005 Keye et al; licensee BioMed Central Ltd.
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
William R Keye,1 Bobby Webster,2 Richard Dickey,3 Stephen Somkuti,4 Jack Crain,5 and M Joseph Scobeycorresponding author6
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
corresponding authorCorresponding author.
William R Keye: wkeye/at/beaumont.edu; Bobby Webster: BW/at/womans.com; Richard Dickey: renee/at/fertilityinstitue.com; Stephen Somkuti: SSomkuti/at/abington-repromed.com; Jack Crain: jack.crain/at/integramed.com; M Joseph Scobey: joe.scobey/at/ferring.com
Received June 27, 2005; Accepted November 9, 2005.
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.
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.
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