Data reported on long-acting FSH preparation.

2002 OCT 17 - (NewsRx.com & NewsRx.net) -- "A long-acting FSH [follicle-stimulating hormone] preparation has been developed by site-directed mutagenesis and gene transfer techniques," researchers in the Netherlands report.

I.J.M. Duijkers and colleagues, Dinox Medical Investigations, conducted an open-label trial in which they "investigated the pharmacokinetic and pharmacodynamic properties of FSH-CTP (corifollitropin alpha, Org 36286) in healthy female volunteers. Twenty-four subjects were treated with a high-dose oral contraceptive (OC) to suppress pituitary function. A single dose of 15, 30 or 60 micrograms FSH-CTP was injected (s.c., eight subjects per dose group) and seven of these 24 subjects were subsequently treated with a single dose of 120 micrograms," the researchers explained.

They reported "maximum serum FSH-CTP concentrations (0.42, 0.66, 1.49 and 3.27 ng/ml after administration of 15, 30, 60 and 120 micrograms Org 36286, respectively) were reached between 36 and 48 hours after injection and t[subscript]1/2 varied between 60 and 75 hours.

"Dose proportionality was shown across the studied dose range, whereas t[subscript]max and t[subscript]1/2 were dose independent," Duijkers and colleagues said.

"In most subjects follicular growth was observed; the number and maximum diameter of the follicles increased with the dose. Follicles with a diameter greater than or equal to 8.0 mm were observed only in the 60- and 120-microgram dose groups, diameters between 12.0 and 15.9 mm occurred only in the 120-microgram group.