A PROSPECTIVE, DOUBLE-BLIND, SPLIT-SUBJECT STUDY ON LOCAL SKIN REACTIONS AFTER ADMINISTRATION OF HUMAN MENOPAUSAL GONADOTROPIN PREPARATIONSTO HEALTHY FEMALE VOLUNTEERS

This study was designed to investigate local reactions after the intra cutaneous (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 bo th Humegon (Organon, Oss, The Netherlands) and Pergonal (Serono, Genev a, Switzerland) at six different sites on their bodies, Local pain, in duration and erythema were registered at 2, 4 and 24 h after administr ation, No pain was observed, At 4 h after administration, Pergonal-tre ated sites showed more induration (P = 0.008) and greater surfaces of erythema (P < 0.001) than Humegon-treated sites, Batches of Pergonal s howed variation in the surface of erythema induced (P < 0.001), indica ting heterogeneity of the batches tested.