Prospective analysis of occurrence and management of breakthrough bleeding during an extended oral contraceptive regimen

Objective The purpose of this study was to assess the bleeding patterns of an extended oral contraceptive (OC) regimen and management of breakthrough bleeding/breakthrough spotting (BTB/BTS). Study design This was a single-center prospective analysis of self-rated menstrual flow during a 21/7-day versus a 168-day extended regimen of on OC containing 3 mg of drosperinone and 30 mcg of ethinyl estradiol (DRSP/EE) with institution of a randomized protocol to manage BTB/BTS. Results Of the 111 patients initiating the extended OC regimen, 102 (92%) completed the 168-day regimen. Subjects having a heavier daily flow rating during the 21/7-day pre-extension cycle had greater daily flow ratings (P< .001) and tended to have earlier occurrence of BTB during the extended regimen (P = .07) than subjects with lighter daily flow ratings. If BTB/BTS of at least 7 consecutive days occurred, patients were randomized to taking a 3-day hormone free interval (HFI) versus continuing active pills. Instituting a 3-day HFI was significantly more effective in resolving BTB/BTS than continuing active pills (P< .0001). Patients with heavier daily flow ratings during the 21/7-day cycle were not more likely to be randomized for BTB/BTS than those with lighter flow ratings (P = .53). Conclusion A 168-day extended regimen of DRSP/EE had an acceptable bleeding profile with a high continuation rate. Bleeding during the extended cycle was effectively managed with institution of a 3-day HFI.