Abstract
Metabolic parameters were studied in 30 patients over 12 treatment cycles in a double-blind randomized comparative trial of the new progestogen gestoden in a triphasic formulation against a fixed dose combination pill containing desogrestrel, in Bandung, Indonesia. The results of this laboratory experience affirm findings in similar previous metabolic studies that: (1) the changes induced by modern low-dose pills are clinically and statistically insignificant; (2) throughout the treatment cycles, the values of the various laboratory tests remain well within the normal range; and (3) the favorable balance between coagulation and fibrinolysis is maintained.
Results of lipoprotein, coagulation, fibrinolytic and liver function tests in 27 patients are presented. Gestoden's pharmacologic profile, and the worldwide clinical experience with the triphasic gestoden formulation in 4285 women are discussed.
Resumé
A Bandung en Indonésie, on a procédé à une étude des paramètres métaboliques chez trente patientes pendant 12 cycles de traitement dans le cadre d'un essai randomisé en double-aveugle. Cette étude comparait un nouveau protestogène, le gestoden, de formule triphasique, à une pillule comportant un mélange fixe contenant du désogestrel. Les résultats de cette expérience en laboratoire confirment les constatations faites précédemment lors d'études métaboliques similaires, à savoir que: (1) les changements apportés par les pillules modernes minidoses ne sont pas significatifs des points de vue clinique et statistique: (2) pendant les cycles de traitement, les valeurs des divers tests en laboratoire restent bien dans les limites normales; et (3) l'équilibre entre coagulation et fibrinolyse est maintenu de façon favorable.
Cette étude présente les résultats des tests, chez 27 patientes, de lipoprotéine, de coagulation, de fibrinolyse et de la fonction hépatique. Elle examine également le profil pharmacologique du gestoden ainsi que l'expérience clinique sur le plan mondial de la formule triphasique du gestoden sur 4285 femmes.
Resumen
En Bandung, Indonesia, se realizó un estudio de los parámetros metabólicos de treinta pacientes durante 12 ciclos de tratamiento, en un ensayo al azar doble ciego. Este estudio comparaba un nuevo progestógeno, gestoden, de fórmula trifásica, con una píddora combinada de dosis fija que contenía desogestrel. Los resultados de esta experiencia de laboratorio confirman las constataciones hechas anteriormente en estudios metabólicos similares, a saber, que: 1) los cambios aportados por las píldoras modernas de dosis baja no son significativos desde el punto de vista clínico y estadístico; 2) durante los ciclos de tratamiento, los valores de las diversas pruebas de laboratorio permanecen esencialmente dentro de los límites normales; 3) el equilibro entre la coagulación y la fibrinólisis se mantiene de modo favorable.
Este estudio presenta los resultados de las pruebas, entre 27 pacientes, de lipoprotreína, coagulación, fibrinólisis y función hepática. Examina asimismo el perfil farmacológico del gestoden así como la experiencia clínica mundial de la fórmula trifásica del gestoden en 4.285 mujeres.
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Agoestina, T., Sabarudin, U. & Hoppe, G. A study comparing a gestoden triphasic formulation with a fixed combination OC. Adv Contracept 5, 71–84 (1989). https://doi.org/10.1007/BF01849474
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DOI: https://doi.org/10.1007/BF01849474