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Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

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: a pooled analysis.

Author information

1
The Family Federation of Finland, Turku Clinic, Turku, Finland. marja-leena.anttila@vaestoliitto.fi.
2
Department of Gynaecology and Obstetrics, District Hospital of Dornbirn, Dornbirn, Austria.
3
Department of Pediatrics, Obstetrics and Reproductive Medicine, Division of Obstetrics and Gynecology, University of Siena, Siena, Italy.
4
Global Clinical Development, Women's Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany.

Abstract

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 μg/EE 20 μg 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.

[Indexed for MEDLINE]

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