Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg

• Autor(a) principal: Machado, Rogerio Bonassi
• Data de Publicação: 2020
• Outros Autores: Pompei, Luciano De Melo, Andrade, Rosires, Nahas, Eliana [UNESP], Guazzelli, Cristina, Wender, Maria Celeste, Cruz, Achilles Machado
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UNESP
• Texto Completo: http://dx.doi.org/10.2147/IJWH.S238294; http://hdl.handle.net/11449/200341
• topic: Bleeding profile; Combined oral contraceptives; Drospirenone; Extended regimen; Low dose oral contraceptive

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.