A prospective, double-blind, split-subject study on local skin reactions after administration of human menopausal gonadotrophin preparations to healthy female volunteers.
This study was designed to investigate local reactions after the intracutaneous (i.c.) administration of two human menopausal gonadotrophin preparations. For this purpose, 20 healthy female volunteers received six i.c. injections simultaneously, viz. three different batches of both Humegon (Organon, Oss, The Netherlands) and Pergonal (Serono, Geneva, Switzerland) at six different sites on their bodies. Local pain, induration and erythema were registered at 2, 4 and 24 h after administration. No pain was observed. At 4 h after administration, Pergonal-treated sites showed more induration (P = 0.008) and greater surfaces of erythema (P < 0.001) than Humegon-treated sites. Batches of Pergonal showed variation in the surface of erythema induced (P < 0.001), indicating heterogeneity of the batches tested.
Odink
J
J
TNO Centre for Controlled Clinical Trials, Zeist, The Netherlands.
Zuiderwijk
P B
PB
Schoen
E D
ED
Gan
R A
RA
D000328:Adult; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology*; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects* / Q000302:isolation & purification; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods; D011446:Prospective Studies; D013997:Time Factors
D008596:Menotropins