Author(s):
Machado, Rogerio Bonassi ; Pompei, Luciano De Melo ; Andrade, Rosires ; Nahas, Eliana [UNESP] ; Guazzelli, Cristina ; Wender, Maria Celeste ; Cruz, Achilles Machado
Date: 2020
Persistent ID: http://hdl.handle.net/11449/200341
Origin: Oasisbr
Subject(s): Bleeding profile; Combined oral contraceptives; Drospirenone; Extended regimen; Low dose oral contraceptive; Bleeding profile; Bleeding profile; Combined oral contraceptives; Combined oral contraceptives; Drospirenone; Drospirenone; Extended regimen; Extended regimen; Low dose oral contraceptive; Low dose oral contraceptive
Description
Made available in DSpace on 2020-12-12T02:04:04Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-01-01
Objective: 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.
Department of Gynecology and Obstetrics Jundiaí School of Medicine
Department of Gynecology and Obstetrics ABC School of Medicine
Department of Gynecology and Obstetrics Federal University of Parana
Department of Gynecology and Obstetrics Botucatu Medical School (Unesp)
Department of Obstetrics Federal University of Sao Paulo
Department of Gynecology and Obstetrics Federal University of Rio Grande do Sul
Department of Clinical Research Libbs Farmacêutica Ltda
Department of Gynecology and Obstetrics Botucatu Medical School (Unesp)
