title: Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive.
abstract: OBJECTIVE
  Safe and effective contraceptive options for obese women are becoming more important due to the obesity epidemic within the United States. This study evaluated the impact of body mass index (BMI) on efficacy, safety and bleeding patterns during use of an ultra-low-dose combined oral contraceptive (COC).
  
  
  METHODS
  Data are from a Phase 3 clinical efficacy and safety study of an ultra-low-dose COC containing 1.0-mg norethindrone acetate and 10-mcg ethinyl estradiol. Pearl Indices, adverse events and bleeding profile were calculated for BMI ranges of <25, 25-30 and >30 kg/m(2).
  
  
  RESULTS
  Of the 1581 participants included in the analysis, 28.3% were overweight, and 18.0% were obese. For women aged 18-45 years, the Pearl Indices were 2.49, 2.32 and 1.89 for women with a BMI <25, 25-30 and >30 kg/m(2), respectively. The ultra-low dose of ethinyl estradiol did not impact scheduled bleeding or intensity of bleeding, but we observed a slight decline in amenorrhea and slight increase in unscheduled bleeding in obese women compared with other BMI categories.
  
  
  CONCLUSIONS
  Our analysis of an ultra-low-dose COC did not find clinically important differences in contraceptive failure rates, adverse events or bleeding profile with increasing BMI.
  
  
  CONCLUSIONS
  Our analysis of an ultra-low ethinyl estradiol dose COC did not find clinically important differences in contraceptive failure rates, adverse events or bleeding profile with increasing BMI. An ultra-low-dose COC provides another safe and effective contraceptive option for obese women.
authors.affiliation: Stanford University School of Medicine, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, 900 Welch Road, Suite 20, Palo Alto, CA, 94304, USA. Electronic address: stevenn@stanford.edu.
authors.forename: Steven T
authors.initials: ST
authors.lastname: Nakajima
authors.affiliation: Actavis, Inc., 400 Interpace Parkway, Parsippany, NJ, 08057, USA. Electronic address: jennifer.pappadakis@actavis.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Pappadakis
authors.affiliation: Eastern Virginia Medical School, Department of Obstetrics and Gynecology, 601 Colley Avenue, Norfolk, VA, 23507-2007, USA. Electronic address: archerdf@evms.edu.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
mesh_terms: D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D015992:Body Mass Index; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D009765:Obesity / Q000150:complications; D011247:Pregnancy; D049168:Pregnancy, Unplanned / Q000187:drug effects; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D004997:Ethinyl Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone
keywords: Ethinyl estradiol; Norethindrone acetate; Obesity; Oral contraceptive; Weight