title: Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada.
abstract: BACKGROUND
  The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg.
  
  
  METHODS
  Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events.
  
  
  RESULTS
  Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively.
  
  
  CONCLUSIONS
  Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting.
authors.affiliation: Department of Obstetrics and Gynecology, Queen's University, Kingston, Ontario, Canada. robert.reid@queensu.ca
authors.forename: Robert L
authors.initials: RL
authors.lastname: Reid
authors.forename: Michel P
authors.initials: MP
authors.lastname: Fortier
authors.forename: Lynne
authors.initials: L
authors.lastname: Smith
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.forename: Gary S
authors.initials: GS
authors.lastname: Grubb
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
mesh_terms: D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced*; D002170:Canada; D017326:Clinical Trials, Phase III as Topic; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects*; D004304:Dosage Forms; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects*; D008595:Menorrhagia / Q000503:physiopathology*; D008796:Metrorrhagia / Q000503:physiopathology*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D004304:Dosage Forms; D004997:Ethinyl Estradiol; D016912:Levonorgestrel