Subcutaneously administered Menopur(R), a new highly purified human menopausal gonadotropin

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 IVFTable 1. Overall, subjects in the two treatment groups were comparable both demographically and medically. The only statistically significant difference between the groups was race, with African-Americans comprising 11.5% of the Menopur® group compared with 1.6% of the Repronex® group (P = 0.039). The impact of this difference is unknown. There were no statistically significant differences between the treatment groups in the number of subjects with any AEs, severe AEs, or serious AEs, as shown in Table 2. There were five serious AEs during the study (1 subject in the Menopur® group had OHSS and four subjects in the Repronex® group had one of the following serious AEs: dehydration, an ectopic pregnancy, a right ruptured ovary with secondary hemothorax, and a pelvic abscess). A total of three cases of OHSS were reported (1 subject in the Menopur® group, which was severe and 2 subjects in the Repronex® group, which were mild or moderate). Table 3 lists the AEs with an incidence of ≥ 5% (2 or more subjects). Among these AEs, there were no significant differences between the two groups in the percentage of subjects with any AE and no difference in the intensity of injection site pain. However, there were numerically fewer total AEs in the Menopur® group (n = 131) compared to the Repronex® group (n = 198). This difference was largely attributed to the number of injection site reactions, the single most common AE. When only hMG injections were considered, there were only three (4.9%) subjects in the Menopur® group that reported injection site reactions, whereas 22 (34.4%) subjects in the Repronex® group reported injection site reactions (P < 0.001). Among the three Menopur® subjects with local injection site reactions, all were transient and mild to moderate in intensity, none developed welts/inflammation, and only one subject had localized swelling. These findings contrasted with the 22 subjects in the Repronex® group with injection site reactions, among whom eight developed welts/inflammation (P < 0.001) and four developed swelling (P = 0.328). Conversely, there was no difference in mean scores for injection site pain between the two groups, 2.6 for Menopur® and 2.3 for Repronex® (P = 0.615). Discussion