Clinical Drug Investigation

, Volume 31, Issue 8, pp 519–525

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
  • Leena Anttila
  • Walter Neunteufel
  • Felice Petraglia
  • Joachim Marr
  • Michael Kunz
Original Research Article

DOI: 10.2165/11590260-000000000-00000

Cite this article as:
Anttila, L., Neunteufel, W., Petraglia, F. et al. Clin. Drug Investig. (2011) 31: 519. doi:10.2165/11590260-000000000-00000

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 ®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.

Copyright information

© Adis Data Information BV 2011

Authors and Affiliations

  • Leena Anttila
    • 1
  • Walter Neunteufel
    • 2
  • Felice Petraglia
    • 3
  • Joachim Marr
    • 4
  • Michael Kunz
    • 4
  1. 1.The Family Federation of Finland, Turku ClinicTurkuFinland
  2. 2.Department of Gynaecology and ObstetricsDistrict Hospital of DornbirnDornbirnAustria
  3. 3.Department of Pediatrics, Obstetrics and Reproductive Medicine, Division of Obstetrics and GynecologyUniversity of SienaSienaItaly
  4. 4.Global Clinical Development, Women’s HealthcareBayer HealthCare PharmaceuticalsBerlinGermany
  5. 5.Väestöliitto Fertility Clinics Ltd - Turku ClinicTurkuFinland

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