Long-term safety and efficacy of extremely low-dose combined oral contraception containing 15 µg of ethinylestradiol and 60 µg of gestodene

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.

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