title: Follitropin-beta administered by pen device has superior local tolerance compared with follitropin-alpha administered by conventional syringe.
abstract: 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-beta) or by conventional syringe (delivering 150 IU follitropin-alpha). 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-beta administered by the pen device was far less painful than follitropin-alpha 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.
authors.affiliation: Kendle, Bolognalaan 40, 3584 CJ Utrecht, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Craenmehr
authors.forename: P M
authors.initials: PM
authors.lastname: Bontje
authors.forename: E
authors.initials: E
authors.lastname: Hoomans
authors.forename: G
authors.initials: G
authors.lastname: Voortman
authors.forename: B MJL
authors.initials: BM
authors.lastname: Mannaerts