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Rogerio Bonassi Machado,1 Luciano de Melo Pompei,2 Rosires Andrade,3 Eliana Nahas,4 Cristina Guazzelli,5 Maria Celeste Wender,6 Achilles Machado Cruz7 1Department of Gynecology and Obstetrics, Jundiaí School of Medicine, Jundiaí, São Paulo 13202-550, Brazil; 2Department of Gynecology and Obstetrics, ABC School of Medicine, Santo André, São Paulo 09060-650, Brazil; 3Department of Gynecology and Obstetrics, Federal University of Parana, Curitiba, Paraná 80060-240, Brazil; 4Department of Gynecology and Obstetrics, Botucatu Medical School (Unesp), Botucatu, São Paulo 18618970, Brazil; 5Department of Obstetrics, Federal University of Sao Paulo, São Paulo 04024-002, Brazil; 6Department of Gynecology and Obstetrics, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul 90035-903, Brazil; 7Department of Clinical Research, Libbs Farmacêutica Ltda, São Paulo 01140-050, BrazilCorrespondence: Rogerio Bonassi MachadoDepartamento de Ginecologia e Obstetrícia, Faculdade de Medicina de Jundiaí, R. Francisco Telles, 250, Jundiaí, São Paulo 12202-550, BrazilTel/Fax +55 11 4586 0660Email rbonassi@me.comObjective: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI).Methods: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSPes group) or a 24/4-day cyclic regimen (EE/DRSP24/4 group) and followed for 168 days. In the EE/DRSPes group, a 4-day HFI was allowed whenever unexpected bleeding/spotting persisted for ≥ 7 consecutive days. The participants assessed their bleeding daily as “no bleeding,” “spotting,” or “light,” “moderate,” or “heavy” bleeding according to a predefined scale.Results: EE/DRSPes group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSPes group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved “no bleeding” (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting.Conclusion: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and “no bleeding”. Unexpected bleeding/spotting in the EE/DRSPes group could be managed effectively with a 4-day HFI.Clinical Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.Keywords: bleeding profile, combined oral contraceptives, drospirenone, extended regimen, low dose oral contraceptive |
