Abstract
This trial was designed to determine the differences in effectiveness, clinical acceptability, and one-year discontinuation rates of two low-dose oral contraceptives: Lo-Estrin (norethindrone acetate 1.5 mg plus ethinyl estradiol 0.030 mg) and Lo-Femenal (norgestrel 0.30 mg plus ethinyl estradiol 0.030 mg) in 148 Mexican women. In addition, the effects of both oral contraceptive preparations on blood lipids were prospectively evaluated in a subgroup of 41 women.
The results indicated that there were no differences in pregnancy rates, discontinuation or clinical acceptability between the two groups. The lipid changes observed were minimal for the Lo-Femenal subgroup and somewhat greater for the Lo-Estrin group, mainly an increase in serum triglycerides. These changes were interpreted as estrogen induced effects of norethindrone-containing oral contraceptives. Overall, the data indicate that both Lo-Femenal and Lo-Estrin are effective and safe combined oral contraceptives.
Résumé
Cette étude, menée auprès de 148 Mexicaines avait pour but de déterminer les différences entre deux contraceptifs oraux faiblement dosés: Lo-Estrin (1,5 mg d'acétate de noréthindrone plus 0,030 mg d'éthynil oestradiol) et Lo-Femenal (0,30 mg de norgestrel plus 0,030 mg d'éthynil oestradiol), du point de vue de l'efficacité, de la tolérance clinique et du taux d'abandon au cours de la première année. Ont et outre été évalués, dans une étude prospective chez un sous-groupe de 41 femmes, les effects éventuels de ces deux contraceptifs oraux sur les lipides sanguins.
Les résultats n'indiquent pas de différence entre les deux groupes quant au nombre de grossesses, au taux d'abandon ou à la tolérance. Les modifications lipidiques étaient minimes pour le sous-groupe L-Femenal et légèrement plus importantes pour le groups Lo-Estrin, essentiellement sous la forme d'une augmentation des triglycérides sériques. On a attribué ces modifications aux effects oestrogènes des contraceptifs oraux contenant du noréthindrone. Dans l'ensemble, les résultats ont indiqué que ces deux contraceptifs combinés sont efficaces et sans danger.
Resumen
Este estudio, realizado entre 148 mexicanas, tuvo por objeto determinar las diferencias entre dos anticonceptivos orales de dosis baja: Lo-Estrin (1,5 mg de acetato de noretindrona más 0,030 mg de etinil estradiol) y Lo-Femenal (0,30 mg de norgestrel más 0,030 mg de etinil estradiol), desde el punto de vista de la eficacia, tolerancia clínica y proporción de abandono en el primer año. Además, se evaluaron, en un estudio prospectivo de un subgrupo de 41 mujeres, los efectos de estos dos anticonceptivos sobre los lípidos sanguíneos.
Los resultados indicaron que no había diferencias entre los dos grupos en cuanto al número de embarazos, proporción de abandono o tolerancia. Las modificaciones de los lípidos eran mínimas en el subgrupo Lo-Femenal y ligeramente más importantes en el grupo Lo-Estrin, principalmente bajo la forma de un incremento de los triglicéridos séricos. Estas modificaciones se han atribuido a los efectos de los estrógenos de los anticonceptivos orales que contienen noretindrona. En general, los resultados indicaron que estos dos anticonceptivos combinados son eficaces y carecen de peligro.
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Garza-Flores, J., Martínez, M., Valles de Bourges, V. et al. Comparative assessment of two low-dose oral contraceptives, Lo-Femenal and Lo-Estrin, in Mexican women. Adv Contracept 8, 291–301 (1992). https://doi.org/10.1007/BF02042587
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DOI: https://doi.org/10.1007/BF02042587