title: Prospective analysis of occurrence and management of breakthrough bleeding during an extended oral contraceptive regimen.
abstract: 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).
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Scott & White Memorial Hospital, Texas A & M University System Health Science Center College of Medicine, Temple, TX 76508, USA. psulak@swmail.sw.org
authors.forename: Patricia J
authors.initials: PJ
authors.lastname: Sulak
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Kuehl
authors.forename: Andrea
authors.initials: A
authors.lastname: Coffee
authors.forename: Sherilyn
authors.initials: S
authors.lastname: Willis
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects*; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; C035144:drospirenone