The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days

Abstract

Objective To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin® [30 μg ethinylestradiol (EE) and 3 mg drospirenone (DRSP)]. Methods Using daily diaries, 177 women recorded bleeding events throughout the 126-day cycle. At end of treatment, the women completed questionnaires reflecting their satisfaction with the extended regimen. A subset of 30 women underwent endometrial histology sampling after completion of the extended regimen. Results Of 177 women assigned to the extended regimen, 80.8% completed the extended 126-day regimen. Approximately 40% of the women reported complete absence of bleeding, while in 60% a shift towards less intense bleeding was observed. The first onset of bleeding occurred after a median of 99.0 days into the extended cycle. The acceptance of the extended regimen was high, with 68.4% of the women expressing satisfaction. The general safety profile with the extended use was comparable to that seen with the conventional 21+7-day regimen. All endometrial biopsies with sufficient material for analysis were normal and supported the endometrial safety of the extended regimen. Conclusion This study showed that the continuous use of a 30-μg EE and 3-mg DRSP formulation over 126 days was safe, efficacious, well accepted by the users and resulted in a considerable reduction of bleeding.