Long-term safety and efficacy of extremely low-dose combined oral
contraception containing 15 µg of ethinylestradiol and 60 µg of gestodene
D. Driák, D. Kolarík
Department of Gynaecology and Obstetrics of the 1st Medical Faculty of
Charles University and Teaching Hospital Na Bulovce, Prague, Czech Republic
Introduction: The biggest advancement of combined oral contraception
(COC) over the last 40 years consists of the reduction in doses of hormones to
eliminate side effects. 15 µg of ethinylestradiol is the lowest dose that has
been ever reached.
Objectives: The purpose of our study was to evaluate the long-term
safety, efficacy, and side effects, as well as the reasons for discontinuation
in patients using the extremely low-dose COC containing 15 µg of
ethinylestradiol and 60 µg of gestodene in each tablet.
Design & Methods: From October 2001 untill December 2003, in 1144
cycles, in 88 women between 13 and 49, contraceptive’s reliability and changes
in gynaecological findings, body weight, blood pressure, biochemical parameters,
cycle control and side effects were observed. The reasons for discontinuation
were analysed.
Results: The contraceptive’s reliability was absolute. There were no
significant changes in body weight, blood pressure, and biochemical parameters.
We diagnosed 8,7 % HPV infection and 1,9 % CIN I. The frequency of breakthrough
bleeding was suprisingly low (5,8 %), evidently for the reason of the relatively
small BMI (average 21,3 kg/m2). The list of side effects didn¡¯t exceed the
existing one. There were no serious adverse events included in the
thromboembolism.
Conclusions: The extremely low-dose COC is generally tolerated very
well and its level of safety is high. Concerning contraceptive effectiveness, it
can be evidently relied on. The frequency of breakthrough bleeding was
suprisingly small (5,8 %), probably because of the patients¡¯ relatively low
BMI. No case of serious venous complication was observed.
