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Human Reproduction, Vol. 11, No. 1, pp. 61-63, 1996
© 1996 European Society of Human Reproduction and Embryology

research-article

A bioequivalence study of two urinary follicle stimulating hormone preparations: Follegon and Metrodin

H.J. Out1,5, P. G-Schnabel2, F. Rombout2, T.B.P. Geurts3, M.A.R. Bosschaert4 and H.J.T. Coelingh Bennink1

1Medical Research and Development Unit PO Box 20, 5340 BH Oss 2Drug Metabolism and Kinetics PO Box 20, 5340 BH Oss 3Medical Services Department, NV Organon PO Box 20, 5340 BH Oss 4UGene Research BV, Bolognalaan 40, 3584 CJ Utrecht, The Netherlands

Correspondence: 5To whom correspondence should be addressed

The purpose of this study was to demonstrate bioequival-ence between two follicle stimulating hormone (FSH)-only gonadotrophin preparations (Follegon® and Metrodin1®) after a single i.m. injection of 300IU FSH in-vivo bioactivity. A total of 16 healthy normally cycling females were treated for 7 weeks with a high-dose oral contraceptive containing 50 µg ethinyl oestradiol plus 2.5 mg lynestrenol (Lyndiol®) to suppress endogenous gonadotrophin production. After 3 and 5 weeks of oral contraceptive treatment, each subject received 300 IU Follegon or Metrodin in a random order. Frequent blood sampling was performed to measure immunoreactive FSH for pharmacokinetic analysis. After normalization for the immunodose administered, Follegon and Metrodin were bioequivalent with respect to the extent and the rate of absorption, the elimination half-life and plasma clearance per kg. The time taken to reach peak plasma FSH concentrations was shorter with Follegon than with Metrodin. Because bioequivalence was proved for the major pharmacokinetic variables, it can be assumed that Follegon and Metrodin are also equally effective in ovula-tion induction, in-vitro fertilization and embryo transfer programmes and the treatment of male infertility.

Key words: bioequivalence/FSH/gonadotrophins/urofolIitro-phin


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G. Voortman, J. van de Post, R. C. Schoemaker, and J. M.A. van Gerven
Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon(R)) by Pen-injector and syringe
Hum. Reprod., July 1, 1999; 14(7): 1698 - 1702.
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