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

Am J Obstet Gynecol. 2006 Oct;195(4):935-41. doi: 10.1016/j.ajog.2006.02.048. Epub 2006 May 2.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Androstenes / administration & dosage
  • Contraceptives, Oral, Combined / administration & dosage*
  • Drug Administration Schedule
  • Ethinyl Estradiol / administration & dosage
  • Female
  • Humans
  • Menstruation / drug effects*
  • Middle Aged
  • Prospective Studies


  • Androstenes
  • Contraceptives, Oral, Combined
  • Ethinyl Estradiol
  • drospirenone