Follitropin-β administered by pen device has superior local tolerance compared with follitropin-α administered by conventional syringe

• Published in: Reproductive biomedicine online 2001, Vol.3 (3), p.185-189
• Main Authors: Craenmehr, E, Bontje, PM, Hoomans, E, Voortman, G, Mannaerts, BMJL
• Format: Article
• Language: English
• Subjects: injection; local tolerance; pain at injection site; pen device; recombinant FSH; self-administration
• ISSN: 1472-6483; 1472-6491
• DOI: 10.1016/S1472-6483(10)62033-0

A receiver- and assessor-blind, randomized, single-centre, crossover study was performed in 60 healthy women volunteers, to compare the local tolerance of two recombinant FSH preparations administered by a pen device (delivering 150 IU follitropin-β) or by conventional syringe (delivering 150 IU follitropin-α). Volunteers were randomized to one of two treatment sequences: pen device followed by conventional syringe, or the reverse. Each preparation was injected once, subcutaneously in the umbilical region and local tolerance reactions were assessed within 5 min, at 1 and 24 h after each administration. In addition, subjects were asked to rate the pain experienced during a period of 24 h after each injection by means of a visual analogue scale (VAS). At administration (within 5 min), severe to moderate pain was experienced in 70.0% of subjects injected by the conventional syringe, whereas only 21.7% of subjects treated with the pen device experienced pain. This difference was highly significant ( P ≤ 0.001). The overall pain score (VAS) was low but significantly lower in subjects treated with the pen device ( P ≤ 0.01). In this study, follitropin-β administered by the pen device was far less painful than follitropin-α administered by conventional syringe. The pen device is the first multiple-use device available for the self-administration of recombinant FSH (rFSH) during ovarian stimulation for assisted reproduction.