Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen

Hernádi, László; Marr, Joachim; Trummer, Dietmar; De Leo, Vincenzo; Petraglia, Felice

doi:10.1016/j.contraception.2009.01.016

« Previous Next »Contraception
Volume 80, Issue 1 , Pages 18-24, July 2009

Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen☆

László Hernádi
- Department of Obstetrics and Gynaecology, Markhot F. Heves County Hospital, Széchenyi út 27, 3300 Eger, Hungary
Joachim Marr
- Clinical Development Women's Healthcare, Bayer Schering Pharma AG, D-13342 Berlin, Germany
- Corresponding author. Medical Development Female Contraception, Bayer Schering Pharma AG, D-13342 Berlin, Germany. Tel.: +49 30 468 17617; fax: +49 30 468 15348.
Dietmar Trummer
- Global Clinical Statistics, Bayer Schering Pharma AG, D-13342 Berlin, Germany
Vincenzo De Leo
- Department of Pediatrics Obstetrics and Reproductive Medicine, Division of Obstetrics and Gynecology, University of Siena, 53100 Siena, Italy
Felice Petraglia
- Department of Pediatrics Obstetrics and Reproductive Medicine, Division of Obstetrics and Gynecology, University of Siena, 53100 Siena, Italy

Received 27 May 2008; received in revised form 23 January 2009; accepted 28 January 2009. published online 19 March 2009.

Abstract

Objective

The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen).

Study Design

In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18–35 years with a body mass index of less than 30 kg/m² received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies.

Results

Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for ‘perfect use’ of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles.