In a post marketing surveillance study the local injection site reactions after subcutaneous administration of hMG (Menogon), HP-hMG (Menopur) or rFSH (Puregon or Gonal-F), the total dosage and the duration of treatment were studied. Materials and methods: Data were collected prospectively from 784 subfertile female patients that were treated for the first time with gonadotropins. Incidence and severity of local side effects were recorded by the physician using hand held computers at each

more »

... Data were analyzed by the independent Netherlands Organisation for Applied Scientific Research (TNO). Data were dichotomized near the median value and logistic regression analysis was performed. By recording visit dates and daily dosages, the duration of treatment and total dosages given could be determined. Results with hMG and rFSH were related to those with HP-hMG. Results: Demographic data of patients treated with hMG (n=268), HP-hMG (n=151) and rFSH (n=365) patients were comparable, including the incidence of allergic reactions in the anamnesis. The incidence of any local injection site reaction of hMG was 24.5% (OR=5.4, 95% CI 2.8-10) and of rFSH 6.8% (OR 1.24, 95% CI 0.64-2.4) compared to HP-hMG (5.6%). Not only the incidence but also the severity of most of the side effects observed after the use of hMG differed significantly from that of HP-hMG: redness OR 12 (CI 2.7-61), size OR 6.5 (CI 1.5-27), pain OR 1.0 (CI 0.29-3.7), itching OR 5.8 (CI1.4-24), swelling OR 10 (CI 2.5-41) and duration OR 8.5 (CI 2.2-33). There were no significant differences with respect to these aspects between HP-hMG and rFSH. In twenty five percent of the patients treatment consisted of ovulation induction (OI) or intra uterine insemination (IUI) and in 75% of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with no difference between treatment groups. Treatment duration and total dosages (days/IU) for OI/IUI were: hMG 9.7/741, HP-hMG 9.7/742 and rFSH 10.9/740. For IVF/ICSI these data were: hMG 9.7/2190, HP-hMG 10.1/2110 and rFSH 9.8/1999. Variant analysis revealed that the gonadotropin preparation had no significant effect on treatment duration or dosage, neither for OI/IUI nor for IVF/ICSI. Conclusions: Selection bias in this post marketing surveillance study was prevented by including naïve patients only. HP-hMG showed a lower incidence and severity of injection site reactions compared to the hMG. HP-hMG and rFSH were comparable with respect to injection site reactions, duration of treatment and total dosage used.