Endometriosetherapie mit Enantone®-Gyn Monats-Depot

In: Leuprorelinacetat — Ein neues GnRH-Analogon · 1992 · pp. 51–61 · doi:10.1007/978-3-642-77666-3_6 · W2185173415
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This non-comparative Phase 3 study evaluated the efficacy, safety, and tolerability of leuprorelin acetate in 104 women with endometriosis over six months.

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This non-comparative, multicenter Phase 3 study evaluated the efficacy, safety, and tolerability of the GnRH analog leuprorelin acetate (Enantone®-Gyn Monats-Depot) in 104 women with endometriosis over 6 months. The treatment is described as inducing reversible hypoestrogenism via down-regulation of the hypothalamic-ovarian axis, and the paper reports that 70 participants had an additional 6-month follow-up period. A major stated limitation is that the study is not comparative, meaning it does not directly contrast leuprorelin with alternative treatments or controls. This paper is centrally about endometriosis—specifically the Phase 3 assessment of leuprorelin acetate (Enantone®-Gyn Monats-Depot) for endometriosis therapy.

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Zusammenfassung Durch die rasche Entwicklung der verschiedenen Gonadotropin- Releasinghormon-Analoga (GnRH-Analoga) haben sich für die medikamentöse Behandlung der Endometriose neue Möglichkeiten ergeben. Die Gabe des GnRH-Analogons bewirkt einen reversiblen Hypoöstrogenismus durch die Down-Regulation der hypothalamisch- ovariellen Achse. In zahlreichen Studien konnte der günstige Einfluß von GnRH-Analoga auf die Endometriose dokumentiert werden [1–7]. In der vorliegenden, nicht vergleichenden, multizentrischen Phase-3-Studie wird über die Ergebnisse einer Untersuchung bei 104 Frauen mit Endometriose berichtet, die während einer Dauer von 6 Monaten mit dem GnRH-Analogon Leuprorelinacetat (Enantone®-Gyn Monats-Depot) behandelt wurden. Bei 70 dieser Patientinnen konnte bereits eine Follow-up-Periode von einem halben Jahr überblickt werden. Es war das Ziel dieser Studie, die Wirksamkeit, Sicherheit und Verträglichkeit von Leuprorelinacetat zu überprüfen. Preview Unable to display preview. Download preview PDF. Similar content being viewed by others Literatur Shaw RW, Fraser HM, Boyle H (1983) Intranasal treatment with luteinising hormone releasing hormone agonist in women with endometriosis. Br Med J 287: 1667 Lemay A, Maheux R, Faure N, Jean C, Fazekas ATA (1984) Reversible hypogonadism induced by a luteinizing hormone-releasing hormone ( LH-RH) agonist (buserelin) as a new therapeutic approach for endometriosis. Fertil Steril 41: 863–871 Schriock E, Monroe SE, Heinzl M, Jaffe RB (1985) Treatment of endometriosis with a potent agonist ol gonadotropin-releasing hormone (nafarelin). Fertil Steril 44: 583–588 Franssen AMHW, Rolland R, Chadha DR, Willemsen WNP, Vemer HM (1986) Treatment with a luteinising hormone-releasing hormone analogue (buserelin) in danazol-resistant endometriosis patients. Eur J Obstet Gynecol Reprod Biol 23: 379 Franssen AMHW, Kauer FM, Chadha DR, Zijlstra JA, Rolland R (1989) Endometriosis: treatment with gonadotropin-releasing hormone agonist Buserelin. Fertil Steril 51: 401–408 Steingold KA, Cedars M, Lu JKH, Rändle D, Judd HL, Meldrum DR (1987) Treatment of endometriosis with a long acting gonadotropin-releasing hormone agonist. Obstet Gynecol 69: 403 Henzl MR, Corson SL, Mohissi K, Buttram VC, Berqvist C, Jacobson J (1988) Administration of nasal nafarelin as compared with oral danazol for endometriosis. N Engl J Med 318: 485 The American Fertility Society (1985) Revised American Fertility Society classification of endometriosis: 1985. Fertil Steril 43: 351–352 Gerhard I, Bechtold E, Eggert-Kruse W, Heberling D, Runnebaum B (1990) Value of endometrial biopsies and serum hormone determinations in women with infertility. Hum Reprod 5: 906–914 Gerhard I, Becker T, Eggert-Kruse W, Klinga K, Runnebaum B (1991) Thyroid and ovarian function in infertile women. Hum Reprod 6: 338–345 Yamazaki I, Okada H (1980) A radioimmunoassay for a highly active luteinizing hormone-releasing hormone analogue and relation between the serum level of the analogue and that of gonadotropin. Endocrinol Jp 27: 593–605 Dlugi AM, Miller JD, Knittle J (1990) Lupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a randomized, placebo- controlled, double-blind study. Fertil Steril 54: 419–427 Dlugi AM, Rufo S, D’Amigo JF, Seibel MM (1988) A comparison of the effects of Buserelin versus danazol on plasma lipoproteins during treatment of pelvic endometriosis. Fertil Steril 49: 913–916 Dmowski WP, Radwanska E, Binor Z, Tumman I, Pepping P (1989) Ovarian suppression induced with Buserelin or Danazol in the management of endometriosis. A randomized comparative study. Fertil Steril 51: 395–400 Kiesel L, Thomas K, Tempone A, Trabant H, Widra W, Runnebaum B (1989) Efficacy and safety of Buserelin treatment in women with endometriosis — a multicentre open-label study. Gynecol Endocrinol 3 [Suppl 2]: 5–19 Johansen JS, Riis BJ, Hassager C, Moen M, Jacobson J. Christiansen C (1988) The effect of a gonadotropin-releasing hormone agonist analog (nafarelin) on bone metabolism. J Clin Endocrinol Metab 67: 701–706 Matta WH, Shaw RW, Hesp R, Evans R (1988) Reversible trabecular bone-density loss following induced hypoestrogenism with the GnRH analogue Buserelin in premenopausal women. Clin Endocrinol 29: 45–52 Editor information Editors and Affiliations Rights and permissions Copyright information © 1992 Springer-Verlag Berlin Heidelberg About this paper Cite this paper Gerhard, I., von Holst, T., Runnebaum, B. (1992). Endometriosetherapie mit Enantone®-Gyn Monats-Depot. In: Runnebaum, B., Breckwoldt, M. (eds) Leuprorelinacetat — Ein neues GnRH-Analogon. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-77666-3_6 Download citation DOI: https://doi.org/10.1007/978-3-642-77666-3_6 Publisher Name: Springer, Berlin, Heidelberg Print ISBN: 978-3-540-55721-0 Online ISBN: 978-3-642-77666-3 eBook Packages: Springer Book Archive

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