Bleeding Pattern and Management of Unexpected Bleeding/Spotting with an Extended Regimen of a Combination of Ethinylestradiol 20 mcg and Drospirenone 3 mg

• Published in: International journal of women's health 2020-01, Vol.12, p.235-242
• Main Authors: Bonassi Machado, Rogerio, Pompei, Luciano de Melo, Andrade, Rosires, Nahas, Eliana, Guazzelli, Cristina, Wender, Maria Celeste, Cruz, Achilles Machado
• Format: Article
• Language: English
• Subjects: Amenorrhea; Birth control; bleeding profile; Clinical trials; combined oral contraceptives; Contraceptives; Drospirenone; Drug therapy; Estradiol; Ethinyl estradiol; extended regimen; Hormones; Labels; low dose oral contraceptive; Medical schools; Menstruation; Oral contraceptives; Original Research
• ISSN: 1179-1411; 1179-1411
• DOI: 10.2147/IJWH.S238294

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). 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/DRSP group) or a 24/4-day cyclic regimen (EE/DRSP group) and followed for 168 days. In the EE/DRSP 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. EE/DRSP group experienced fewer days of bleeding than those using a 24/4 cyclic regimen ( < 0.001). After 168 days, 57.5% of women in the EE/DRSP 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. 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/DRSP group could be managed effectively with a 4-day HFI. International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.