The absorption and uptake of recombinant human follicle-stimulating hormone through vaginal subcutaneous injections - A pharmacokinetic study

Reproductive Biology and Endocrinology

Volumn 7, Issue , 2009, Pages 107-

  Hsu, Chao Chin ^a,b   Kuo, Hsin Chih ^c   Hsu, Chao Tien ^d   Gu, Qing ^e  

^a NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^b CHINA MEDICAL UNIVERSITY   (Taiwan)

^c I SHOU UNIVERSITY   (Taiwan)

^d E DA HOSPITAL   (Taiwan)

^e SECOND MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

[No Author keywords available]

Indexed keywords

BUSERELIN ACETATE; PUREGON 300; RECOMBINANT FOLLITROPIN; UNCLASSIFIED DRUG;

ABDOMEN; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG ELIMINATION; DRUG TOLERABILITY; DRUG UPTAKE; FEMALE; HUMAN; HUMAN EXPERIMENT; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VAGINA;

ABSORPTION; ADMINISTRATION, INTRAVAGINAL; ADULT; CROSS-OVER STUDIES; FEMALE; FOLLICLE STIMULATING HORMONE; HUMANS; INJECTIONS, SUBCUTANEOUS; RECOMBINANT PROTEINS; VAGINA;

EID: 70449504068     PISSN: None     EISSN: 14777827     Source Type: Journal    
DOI: 10.1186/1477-7827-7-107     Document Type: Article

References (38)

1. Devroey P, Van Steirteghem A, Mannaerts B, Coelingh Bennink H. First singleton term birth after ovarian super-ovulation with recombinant human follicle stimulating hormone (Org 32489). Lancet 1992, 340:1108. 10.1016/0140-6736(92)93141-9, 1357510.
2. Howles CM, Loumaye E, Giroud DV, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicenter European Phase III study. Hum Reprod 1994, 9:424-439.
3. Out HJ, Mannaerts BMJL, Driessen SGAJ, Coelingh Bennink HJT. A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-virto fertilization. Hum Reprod 1995, 10:2534-2540.
4. Fauser BCJM, van Heusden AM. Manipulation of human ovarian function: physiological concepts and clinical consequences. Endoc Rev 1997, 18:71-106.
5. Devroey P, Mannaerts B, Smitz J, Coelingh-Bennink H, Van Steirteghem A. Clinical outcome of a pilot efficacy study on recombinant human FSH (Org 32489) combined with various GnRH agonist regimens. Hum Reprod 1994, 9:1064-1069.
6. Peng Y. The lived experience of women who quit assisted reproductive technology. Master Thesis 2005, National Yang-Ming University, Institute of Clinical Nursing, Taiwan, Republic of China.
7. Hsu CC, Hsu CT. Conception using vaginal administration of gonadotrophins in IVF: a case report. Reprod Biomed Online 2006, 12:170-173.
8. Pistor M. Un defi therapeutique: lamesotherapie 1979, Paris, France: Malonie, 3.
9. Bulletti C, de Ziegler D, Flamigni C, Giacomucci E, Polli V, Bolelli G, Franceschetti F. Targeted drug delivery in gynecology: the first uterine pass effect. Hum Reprod 1997, 12:1073-1079. 10.1093/humrep/12.5.1073, 9194669.
10. Cicinelli E, de Z. Transvaginal progesterone: evidence for a new functional "portal system" flowing from the vagina to the uterus. Hum Reprod Update 1999, 5:365-372. 10.1093/humupd/5.4.365, 10465526.
11. Pistor M. Mesotherapie. Presse medicale 66e annee 44 1958, 999-1000.
12. Miles RA, Paulson RJ, Lobo RA, Press MF, Dahmoush L, Sauer MV. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscualr and vaginal route: a comparative study. Fertil Steril 1994, 62:485-490.
13. Einer-Jensen N. Countercurrent transfer in the ovarian pedicle and its physiological implications. Oxf Rev Reprod Biol 1988, 10:348-381.
14. Hsu CC, Hsu CT, Gu Q, Wang ST. Intermittent vaginal injections of gonadotrophins for ovarian stimulation in IVF treatment. Reprod BioMed Online 2008, 16:617-620.
15. le Cotonnec J-Y, Porchet HC, Beltrami V, Khan A, Toon S, Rowland M. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH). I. Comparative pharmacokinetics with urinary human FSH. Fertil Steril 1994, 61:669-678.
16. le Cotonnec J-Y, Porchet HC, Beltrami V, Khan A, Toon S, Rowland M. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH). II. Single doses and steady-state pharmacokinetics. Fertil Steril 1994, 61:679-686.
17. Porchet HC, le Cotonnec J-Y. Pharmacokinetic and pharmacodynamic characteristic of recombinant human follicle-stimulating hormone. Assis Reprod Rev 1994, 4:10-117.
18. Mannaerts MJL, Rombout F, Out HJ, Bennink HC. Clinical profiling of recombinant follicle stimulating hormone (rFSH; Puregon): relationship between serum FSH and efficacy. Hum Reprod Update 1996, 2:153-161. 10.1093/humupd/2.2.153, 9079410.
19. Voortman G, Post J, Schoemaker RC, van Gerven JMA. Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon) by Pen-injector and syringe. Hum Reprod 1999, 14:1698-1702. 10.1093/humrep/14.7.1698, 10402370.
20. Dobbs KE, Dumesic DA, Dumesic JA, Shapiro SS. Differences in serum follicle-stimulating hormone uptake after intramuscular and subcutaneous human menopausal gonadotropin injection. Fertil Steril 1994, 62:978-83.
21. Mannaerts B, Fauser B, Shoham Z, Jacobs H, Schoot D, Rombout F, Bouchard P, Bennink HC, Harlin J. Single-dose pharmacokinetics and pharmacodynamics of recombinant human follicle-stimulating hormone (Org 32489*) in gonadotrophin-deficient volunteers. Fertil Steril 1993, 59:108-114.
22. Tozer TN, Rowland M. Introduction to pharmacokinetics and pharmakodynamics. The quantitative basis of drug therapy 2006, Baltimore: Lippincott Williams & Wilkins.
23. Klein J, Lobel L, Pollak S, Ferin M, Xiao E, Sauer M, Lustbader JW. Pharmacokinetics and pharmacodynamics of single-chain recombinant human follicle-stimulating hormone containing the human chorionic gonadotropin carboxyterminal peptode in the rhesus monkey. Fertil Steril 2002, 77:1248-55. 10.1016/S0015-0282(02)03113-8, 12057736.
24. Devroey P, Fauser BC, Platteau P, Beckers NG, Dhont M, Mannaerts BM. Induction of multiple follicular development by a single dose of long-acting recombinant follicle-Stimulating hormone (FSH-CTP, corifollitropin alfa) for controlled ovarian stimulation before in vitro fertilization. J Clin Endoc Metab 2004, 89:2062-2070.
25. Perlman S, Hazel B, Christiansen J, Gram-Nielsen S, Jeppesen CB, Andersen KV, Halkier T, Okkels S, Schambye HT. Glycosylation of an N-terminal extension prolongs the half-life and increases the in vivo activity of follicle stimulating hormone. J Clin Endoc Metab 2003, 88:3227-3235.
26. Welling PG. Pharmacokinetics Processes and mathematics. ACS Monograph 185 1986, 18. Washington, DC: American Chemical Society.
27. Nichols DH, Randall CL. Vaginal Surgery 1976, Baltimore: Williams & Williams.
28. Kaplan, Raincourt. Devenir d'un produit marque injecte par quatre voies differentes. Bulletin SFM (la Societe Francaise de Mesotherapie) 1985, 62.
29. Le Coz J. Traite de mesotherapie 2004, Masson, Paris, France.
30. Chien YW. Transdermal Drug Delivery and Delivery Systems. Novel Drug Delivery Systems 1992, 301-380. New York: Marcel Dekker, Inc, Chien YW, 2.
31. Schoemaker J, van Weissenbruch MM, Scheele F, Meer M. New developments in ovulation induction with gonadotropins using the threshold principle. Studies in Profertility series: Ovarian Endocrinopathies 1994, 2:177-188. London: The Parthenon Publishing Group, Schats R, Schoemaker J.
32. Pal L, Jindal S, Witt BR, Santoro N. Less is more: increased gonadotropin use for ovarian stimulation adversely influences clinical pregnancy and live birth after in vitro fertilization. Fertil Steril 2008, 89:1694-1701. 10.1016/j.fertnstert.2007.05.055, 2601677, 18440515.
33. Richter A, Anton SE, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. Clin Therap 2003, 25:2307-2335.
34. Scholtes MCW, Schnittert BS, van Hoogstraten D, Verhoeven HC, Zrener A, Warne DW. A comparison of 3-day and daily follicle-stimulating hormone injections on stimulation days 1-6 in women undergoing controlled ovarian hyperstimulation. Fertil Steril 2004, 81:996-1001. 10.1016/j.fertnstert.2003.09.043, 15066454.
35. Balasch J, Fabregues F, Creus M, Puerto B, Penarrubia J, Vanrell JA. Follicular development and hormone concentrations following recombinant FSH administration for anovulation associated with polycystic ovarian syndrome: prospective, randomized comparison between low-dose step-up and modified step-down regimens. Hum Reprod 2001, 16:652-656. 10.1093/humrep/16.4.652, 11278212.
36. Fauser BCJM, Mannaerts BMJL, Devroey P, Leader A, Boime I, Baird DT. Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency. Hum Reprod Update 2009, 15:309-321. 10.1093/humupd/dmn065, 19182099.
37. Wooding WM. Planning Pharmaceutical Clinical Trials 1994, New York: Wiley.
38. Machin D, Campbell M, Fayers P, Pinol A. Demonstrating equivalence. Sample Size Tables for Clinical Studies 1987, 99-130. Oxford: Blackwell Science, Machin D, Campbell M, Fayers P, Pinol A, 2.