Human Reproduction, Vol. 12, No. 11, pp. 2379-2384, 1997
© 1997 European Society of Human Reproduction and Embryology
Pharmacodynamics and pharmacokinetics after repeated subcutaneous administration of three gonadotrophin preparations
1 Dinox BV Medical Investigations Nijmegen 2 Department of Obstetrics and Gynaecology, University Hospital Nijmegen St. Radboud Nijmegen 3 NV Organon, Oss The Netherlands
Correspondence: 4To whom correspondence should be addressed at: Dinox BV, Medical Investigations, Groenewoudesweg 317, 6524 Tx Nijmegen, The Netherlands
Recently, several new urinary gonadotrophin preparations have been developed, containing less luteinizing hormone (LH) activity than human menopausal gonadotrophin. Normegon is a gonadotrophin preparation with a follicle stimulating hormone (FSH)/LH ratio of 3:1; Follegon and Metrodin-HP are purified FSH preparations. The aim of the present randomized study was to compare pharmacodynamics, -kinetics and local tolerance of these preparations after repeated s.c. administration. Thirty-six healthy female subjects were treated with Lyndiol contraceptive pills for 5 weeks to suppress endogenous gonadotrophin concentrations. After 3 weeks of Lyndiol treatment, 150 IU of Normegon, Follegon or Metrodin HP were administered once daily, s.c. for 7 days. Blood samples were collected once daily during the fourth and fifth weeks of the study and assayed for FSH and oestradiol. After the last gonadotrophin injection, blood samples were collected more frequently to determine pharmacokinetic parameters of FSH. During the fourth and fifth study weeks, daily ultrasound measurements of follicular growth were performed. Endogenous FSH and LH values were extremely suppressed during Lyndiol treatment. Serum FSH values showed similar patterns in the three groups. The maximum FSH concentration was reached 9–11 h post-injection, the terminal half-life was 43–47 h. The preparations were bioequivalent with respect to FSH immunoreactivity. The number of follicles tended to be larger after Normegon than after Follegon and Metrodin HP treatment, though this was not statistically significant. Serum oestradiol concentrations were significantly higher after Normegon treatment. In general, s.c injections were well tolerated. In conclusion, the three preparations were bioequivalent with respect to FSH immunoreactivity. Nevertheless, the biological activity of Normegon tended to be higher than that of Follegon and Metrodin HP in Lyndiol-suppressed women.
Key words: FSH/gonadotrophin/pharmacodynamics/pharmacokinetics/subcutaneous
Submitted on April 11, 1997; accepted on July 28, 1997.
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