, Volume 31, Issue 8, pp 519-525
Date: 24 Aug 2012

Cycle Control and Bleeding Pattern of a 24/4 Regimen of Drospirenone 3 mg/Ethinylestradiol 20 μg Compared with a 21/7 Regimen of Desogestrel 150 μg/Ethinylestradiol 20 μg

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Background and Objective: The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill (24/4) regimen (YAZ®) with those of desogestrel (DSG) 150 ®g/EE 20 ®g in a 21/7 regimen (Mercilon®), an established European combined oral contraceptive (COC).

Methods: Bleeding data from women aged 17–36 years who received either DRSP 3 mg/EE 20 μg in a 24/4 regimen (n= 1285) or DSG 150 μg/EE 20 μg in a 21/7 regimen (n = 471) during four clinical studies were pooled and analysed over seven treatment cycles.

Results: The maximum intensity of scheduled withdrawal bleeding was ‘normal bleeding’ for >50% of subjects in cycles 1–6 in both treatment groups. Moreover, the incidence of unscheduled intracyclic bleeding during cycles 2–7 was comparable between treatment types (10.2–14.9% in women treated with DRSP 3 mg/EE 20 μg 24/4 vs 8.6–13.8% in women treated with DSG 150 μg/EE 20 μg 21/7). Overall, similar bleeding patterns were observed with both treatments.

Conclusion: DRSP 3 mg/EE 20 μg 24/4 is associated with a bleeding profile and cycle control that is comparable to that of an established, low-dose COC formulation.