title: Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo.
abstract: BACKGROUND
  The study was conducted to evaluate the efficacy and safety for the prevention of pregnancy of a 28-day oral contraceptive (OC) containing 150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days followed by 7 days of 10 mcg EE (Cette-28).
  
  
  METHODS
  A 6-month, prospective, multicenter, single-arm study was conducted in 1302 women aged 18-45 years.
  
  
  RESULTS
  Over six cycles of treatment, the cumulative risk of pregnancy among all treated subjects (n=1262) was 0.9%. The Pearl Index for women 18-35 years of age (n=1042) was 2.20, including 9 pregnancies with estimated conception dates during active drug ingestion or up to 7 days after the last combination tablet. The rate of unscheduled bleeding was low and the duration of scheduled bleeding was approximately 2 days during each of the six treatment cycles. The safety profile was similar to what has been reported for other OCs.
  
  
  CONCLUSIONS
  This low-dose, 28-day OC incorporating 7 days of 10 mcg EE during the hormone free interval is effective and safe for the prevention of pregnancy and is well-tolerated by women.
authors.affiliation: Obstetrics and Gynecology, Baylor College of Medicine, Houston, TX 77011, USA.
authors.forename: Alfred
authors.initials: A
authors.lastname: Poindexter
authors.forename: Kathleen Z
authors.initials: KZ
authors.lastname: Reape
authors.forename: Howard
authors.initials: H
authors.lastname: Hait
mesh_terms: D000328:Adult; D003279:Contraceptives, Oral, Sequential / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008796:Metrorrhagia / Q000209:etiology; D011247:Pregnancy; D016896:Treatment Outcome
chemical_list: D003279:Contraceptives, Oral, Sequential; D004997:Ethinyl Estradiol; D017135:Desogestrel