A bioequivalence study of two urinary follicle stimulating hormone preparations: Follegon and Metrodin
| Autor: | Henk J. Out, M.A.R. Bosschaert, T.B.P. Geurts, H. J. T. Coelingh Bennink, P. G-Schnabel, Ferdy Rombout |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Adult
endocrine system medicine.medical_specialty Adolescent medicine.drug_class media_common.quotation_subject Urine Bioequivalence Lynestrenol Follicle-stimulating hormone Internal medicine medicine Humans Ovulation media_common business.industry Rehabilitation Obstetrics and Gynecology Mestranol Contraceptives Oral Combined Drug Combinations Kinetics Endocrinology Reproductive Medicine Therapeutic Equivalency Female Menotropins Gonadotropin Follicle Stimulating Hormone business hormones hormone substitutes and hormone antagonists Blood sampling medicine.drug Half-Life |
| Zdroj: | Human reproduction (Oxford, England). 11(1) |
| ISSN: | 0268-1161 |
| Popis: | The purpose of this study was to demonstrate bioequival-ence between two follicle stimulating hormone (FSH)-onlygonadotrophin preparations (Follegon® and Metrodin®)after a single i.m. injection of 300IU FSH in-vivo bioactivity.A total of 16 healthy normally cycling females were treatedfor 7 weeks with a high-dose oral contraceptive containing50 Jig ethinyl oestradiol plus 2.5 mg lynestrenol (Lyndiol®)to suppress endogenous gonadotrophin production. After3 and 5 weeks of oral contraceptive treatment, each subjectreceived 300 IU Follegon or Metrodin in a random order.Frequent blood sampling was performed to measureimmunoreactive FSH for pharmacokinetic analysis. Afternormalization for the immunodose administered, Follegonand Metrodin were bioequivalent with respect to the extentand the rate of absorption, the elimination half-life andplasma clearance per kg. The time taken to reach peakplasma FSH concentrations was shorter with Follegon thanwith Metrodin. Because bioequivalence was proved for themajor pharmacokinetic variables, it can be assumed thatFollegon and Metrodin are also equally effective in ovula-tion induction, in-vitro fertilization and embryo transferprogrammes and the treatment of male infertility.Key words: bioequivalence/FSH/gonadotrophins/urofollitro-phinIntroductionThe currently available human gonadotrophin preparationsare derived from urine from either post-menopausal women(human menopausal gonadotrophin; HMG) or pregnant women(human chorionic gonadotrophin; HCG). Although the clinicalefficacy has been solidly established in assisted reproductionprogrammes of the standard HMG preparations containingboth follicle stimulating hormone (FSH) and luteinizing hor-mone (LH) activity in a ratio of 1:1, it has been suggestedthat the use of preparations containing less LH or evencontaining only FSH may have clinical advantages (Chappeland Howies, 1991). Preparations containing only FSH derivedfrom the urine of post-menopausal women (urofollitrophin) |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|