PMID- 16280073 OWN - NLM STAT- MEDLINE DCOM- 20060717 LR - 20181113 IS - 1477-7827 (Electronic) IS - 1477-7827 (Linking) VI - 3 DP - 2005 Nov 9 TI - Subcutaneously administered Menopur, a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex in subjects undergoing in vitro fertilization. PG - 62 AB - 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. FAU - Keye, William R AU - Keye WR AD - William Beaumont Hospital, In Vitro Fertility Clinic, Royal Oak, Michigan, USA. wkeye@beaumont.edu FAU - Webster, Bobby AU - Webster B FAU - Dickey, Richard AU - Dickey R FAU - Somkuti, Stephen AU - Somkuti S FAU - Crain, Jack AU - Crain J FAU - Scobey, M Joseph AU - Scobey MJ LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20051109 PL - England TA - Reprod Biol Endocrinol JT - Reproductive biology and endocrinology : RB&E JID - 101153627 RN - 0 (Organic Chemicals) RN - 0 (Repronex) RN - 61489-71-2 (Menotropins) SB - IM MH - Adolescent MH - Adult MH - Female MH - Fertilization in Vitro/*methods MH - Humans MH - Injections, Subcutaneous/*adverse effects MH - Menotropins/*administration & dosage/adverse effects MH - Organic Chemicals/administration & dosage/adverse effects MH - Pain/etiology PMC - PMC1309620 EDAT- 2005/11/11 09:00 MHDA- 2006/07/18 09:00 PMCR- 2005/11/09 CRDT- 2005/11/11 09:00 PHST- 2005/06/27 00:00 [received] PHST- 2005/11/09 00:00 [accepted] PHST- 2005/11/11 09:00 [pubmed] PHST- 2006/07/18 09:00 [medline] PHST- 2005/11/11 09:00 [entrez] PHST- 2005/11/09 00:00 [pmc-release] AID - 1477-7827-3-62 [pii] AID - 10.1186/1477-7827-3-62 [doi] PST - epublish SO - Reprod Biol Endocrinol. 2005 Nov 9;3:62. doi: 10.1186/1477-7827-3-62.