Subcutaneously administered Menopur, a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex in subjects undergoing in vitro fertilization.
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.


CONCLUSIONS
Menopur SC offers a greater safety and tolerability profile compared to Repronex SC.
Keye
William R
WR
William Beaumont Hospital, In Vitro Fertility Clinic, Royal Oak, Michigan, USA. wkeye@beaumont.edu
Webster
Bobby
B
Dickey
Richard
R
Somkuti
Stephen
S
Crain
Jack
J
Scobey
M Joseph
MJ
D000293:Adolescent; D000328:Adult; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D007279:Injections, Subcutaneous / Q000009:adverse effects*; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects; D009930:Organic Chemicals / Q000008:administration & dosage / Q000009:adverse effects; D010146:Pain / Q000209:etiology
D009930:Organic Chemicals; C432248:Repronex; D008596:Menotropins