A comparative clinical trial of Norinyl 1+35 versus Norinyl 1+50 in Merida, Yucatan, Mexico

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Abstract
A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between Norinyl 1+50 (Syntex) and Norinyl 1+35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the Norinyl 1+35 group or to the Norinyl 1+50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the Norinyl 1+35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (ppppppppp<0,05). En los dos grupos, el abandono fue más frecuente entre las mujeres con problemas menstruales. La tabla de supervivencia de la proporción de abandono establecida a los 12 meses indica 52,0 para el grupo de Norinyl 1+35 y 50,7 para el grupo de Norinyl 1+50. Las proporciones de interrupción de supervivencia a los 12 meses ascendieron a 17,8 para el grupo de Norinyl 1+35 y a 22,8 para el de Norinyl 1+50.