Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol.
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.
Lammers
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Medical Services & Product Surveillance Department, Organon International BV, Oss, The Netherlands.
op ten Berg
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D000328:Adult; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects; D017135:Desogestrel; D004997:Ethinyl Estradiol; D005060:Europe; D005260:Female; D006801:Humans; D009652:Norpregnenes; D045167:Progesterone Congeners
D003280:Contraceptives, Oral, Synthetic; D009652:Norpregnenes; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; D017135:Desogestrel