The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days.
OBJECTIVE
To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin [30 microg 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.


CONCLUSIONS
This study showed that the continuous use of a 30-microg 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.
Foidart
Jean-Michel
JM
Department of Obstetrics and Gynecology, University of Liège, B-400 Liège, Belgium.
Sulak
Patricia J
PJ
Schellschmidt
Ilka
I
Zimmermann
Doris
D
D000328:Adult; D000736:Androstenes / Q000008:administration & dosage*; D003276:Contraceptives, Oral / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D017060:Patient Satisfaction; D011446:Prospective Studies; D013997:Time Factors; D014592:Uterine Hemorrhage / Q000453:epidemiology
D000736:Androstenes; D003276:Contraceptives, Oral; D004997:Ethinyl Estradiol; C035144:drospirenone