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Recombinant Human LH:Potential Advantages and Applications
Title: Clinical pharmacology of recombinant human luteinizing hormone: Part I. Pharmokinetics after intravenous administration to healthy female volunteers and comparison with urinary human luteinizing hormone
Author: J. Cotonnec et al
Address: Geneva, Switzerland
Source: Fertility and Sterilty 89:189-194 (February) 1998
Summary:Using twelve healthy pituitary down-regulated females, this prospective, dose escalating ,cross-over study attempts to assess the pharmokinetics after IV administration of a recombinant human LH and then, using a reference hMG preparation containing urinary LH, compares the results . Both recombinant human LH and urinary human LH experienced a rapid distribution phase with an initial half life of 1 hour and were eliminated with a terminal half-life of 10-12 hours. Total serum clearance was 1.7L/h with 4% of the recombinant human LH dose and 30% of the urinary human LH dose eliminated in the urine. A steady state of volume distribution was achieved at approximately 10L. The recombinant human LH was well tolerated at all doses. The authors concluded that "the pharmokinetics of recombinant human LH are linear with dose and similar to those of urinary human LH".
Title:Clinical pharmacology of recombinant human luteinizing hormone: Part II. Bioavailability of recombinant human luteinizing hormone assessed with an immunoassay and in vitro assay
Author: J. Cotonnec et al
Address: Geneva, Switzerland
Source: Fertility and Sterilty 89:195-200 (February) 1998
Summary: Part two of this study finds the original 12 female participants partaking in this prospective, randomized cross-over study. This study phase attempts to assess the single-dose pharmokinetics of recombinant human LH preparation when delivered via IV,IM, and SC route. It was concluded that the the pharmokinetics are similar after IM and SC administration and that one half of this dose is systemically available. It was also noted that the terminal half life of recombinant LH is approximately 12 hours and that this time is slightly lengthened after extravascular administration.
Title:Pharmocokinetic and pharmacodynamic interactions between recombinant human luteinizing hormone and recombinant human follicle-stimulating hormone
Author:J. Cotonnec et al
Address: Geneva, Switzerland
Source: Fertility and Sterilty 89:201-209 (February) 1998
Summary: The final area of this phase one, prospective, randomized, cross-over study looks at the pharmacokinetics of a recombinant human LH preparation and examines its pharmacokinetic and pharmacodynamic interactions with recombinant human follicle stimulating hormone (FSH) in the same twelve pituitary down- regulated females from the previously reviewed studies. Noting inter-individual variability related to ovarian sensitivity, it was observed that ³combined administration of FSH and LH for 7 days was effective in stimulating ovarian follicular development and steroidogenesis. The authorıs assert that no pharmacokinetic or pharmacodynamic interaction was observed between the recombinant LH and FSH and that the recombinant human LH preparation has a low accumulation ratio at steady-state.
Comment: A central component in our theories of ovarian function involve the two cell -two gonadotropin theory of ovarian function. FSH, acting through receptors in the granulosa cells, stimulate granulosa cell division, and thus stimulate follicle growth. FSH also promotes the development of aromatase activity, initiating conversions of androgens to estradiol. LH promotes thecal cell development , which in turn, signals androgen production that serves as substrate for estradiol production in the granulosa cells. All the gonadotropins (Pergonal, Repronex, Humegon) extracted from postmenopausal urine contain an approximate equal mixture of LH and FSH. Metrodin and Fertinex are formulated to have less LH activity in attempt to improve the stimulation in patients with greater levels of endogenous LH, ie PCOS patients. No real difference has been reported in the general success rates among all these preparations. Now there is recombinant FSH (Follistim and Gonal F) and both are equally natural and derived from cell culture in the labortatory. These medications contain no LH. WIth a combination of truly pure LH and FSH it becomes possible to formulate specific combinations of LH and FSH. These fine tuned formulations may elucidate upon a more in-depth understanding of how the ovaries work and possibly allow for very specific treatment modalities. These individualized modalities will hopefully provide for the optimum stimulation regimen. Perhaps, this may also lead to better egg quality and a reduction of hyperstimulation. Certainly, these are ambitious goals, but these are potentially important tools. This three part study represents an early report of this new agent and its release is something to look forward to.
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