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  • Title: Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol.
    Author: Lammers P, op ten Berg M.
    Journal: Acta Obstet Gynecol Scand; 1991; 70(6):497-500. PubMed ID: 1837199.
    Abstract:
    Results are presented of a Phase III international multicentre trial to study the effect of a new low-dose oral contraceptive (OC) containing 20 micrograms ethinylestradiol and 150 micrograms desogestrel (Mercilon) regarding efficacy, cycle control, blood pressure, and acceptability. Altogether 1,684 women from 12 European countries were included in the study. Four pregnancies occurred, 3 of them patient failures, one tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects--headache, nausea and breast tension--was already low after the first cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus proved to be an effective, safe and well-accepted ultra low-dose oral contraceptive. Results are presented of a phase 3 international multicenter trial to study the effect of a new, low-dose oral contraceptive (OC) containing 20 mcg ethinyl estradiol and 150 mcg desogestrel (Mercilon) with regard to efficacy, cycle control, blood pressure, and acceptability. In total, 1684 women from 12 European countries were included in the study. 4 pregnancies occurred, 3 of them patient failure and 1 tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects, i.e., headache, nausea, and breast tenderness, was already low after the 1st cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus far proven to be an effective, safe, and well-accepted ultra low-dose OC.
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