Open AccessGerman Trial of an Oral Contraceptive Containing 0.150 mg Desogestrel Plus 0.020 mg Ethinylestradiol
Author(s) -
NevinnyStickel J.
Publication year - 1987
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.3109/00016348709156490
Subject(s) - medicine , ethinylestradiol , desogestrel , multicenter trial , menstrual cycle , german , randomized controlled trial , gynecology , metrorrhagia , multicenter study , family planning , population , surgery , research methodology , hormone , environmental health , archaeology , history
. A multicenter trial was carried out by 13 independent German investigators to evaluate a new oral contraceptive combination containing 0.150 mg desogestrel+0.020 mg ethinylestradiol, paying particular attention to cycle control and efficacy. This German trial, being part of a larger European open multicenter study in 12 countries, comprised 235 women and a total of 5758 cycles. Despite the very low estrogen dose, this combination showed a good cycle control. The frequencies of absence of withdrawal bleeding and the occurrence of irregular bleeding, which were already low during the initial treatment cycles, gradually decreased over the subsequent cycles. In most women the amount and duration of withdrawal bleeding were similar to or slightly less than those of the menstrual bleeding before treatment. The combination showed a good contraceptive efficacy. 3 pregnancies (all 3 patient failures) occurred (in the larger European study comprising 1684 women and 25970 cycles, no other patient failures than these 3 German cases occurred; in addition there was one tablet failure). The preparation was well tolerated. There were no serious side effects and the frequency of minor subjective complaints was very low.