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

The effect of a continuous regimen of drospirenone 3 mg/ethinylestradiol 30 μg on Cox-2 and Ki-67 expression in the endometrium

“…Since cyclooxygenase enzymes and prostaglandins are known to play an important role in the development of several conditions such as dysmenorrhoea, endometriosis and menorrhagia, suppression of this enzyme in the endometrium of patients using drospirenone in an extended regimen may explain the advantages of this regimen in controlling menstrual-related symptoms 18 . A positive correlation was also observed between the level of Cox-2 mRNA in the endometrium and the intensity of menorrhagia, further supporting the role for prostaglandins in the regulation of menstrual bleeding 7 .…”

New regimens with combined oral contraceptive pills – moving away from traditional 21/7 cycles

“…One hundred and seventy seven women recorded bleeding events, completed satisfaction questionnaires, and a subset of 30 had endometrial biopsies. Amenorrhoea was induced in 40%, a somewhat lower rate than that reported for the previously discussed EE/LNG extended regimens, but in 60% there was a shift to less intense bleeding; 68% were satisfied with the extended regimen and safety was comparable to that seen in a conventional regimen 40 . A study from Israel compared the same formulation of EE and DRSP in a 21/7 regimen vs. an 84/7 regimen in 137 women; there was a significant reduction in the amount of bleeding in the extendedcycle regimen at six months 41 .…”

Recent advances in hormonal contraception

“…Of 177 women, 81% completed the extended regimen. This study showed that the continuous use of this formulation over 126 days was safe, efficacious, well accepted by the users and resulted in a considerable reduction of bleeding [15].…”