title: Different Pearl Indices in studies of hormonal contraceptives in the United States: impact of study population.
abstract: OBJECTIVE
  To examine the impact of subject characteristics on efficacy as measured by the Pearl Index (PI) in clinical trials and to make study populations similar by matching.
  
  
  METHODS
  Our analysis used US data from four large Phase III studies. We compared results from one fertility control patch study with pooled data from three studies with virtually identical design on oral hormonal contraceptives. First, we identified three characteristics that had the most impact on the PI. Second, we used these three variables and matched subjects from the patch study with those from the oral contraceptive (OC) studies. Finally, we calculated the PIs for matched and unmatched subjects from both the patch study and the OC studies.
  
  
  RESULTS
  A total of 3706 subjects were included in our analysis. The variables 'Hispanic ethnicity', 'previous pregnancy' and 'previous use of hormonal contraceptives' had the most impact on the PI. The PIs for the matched patch cohort and the matched OC cohort were 2.97 and 2.48, respectively. Those for the unmatched patch cohort and the unmatched OC cohort were 10.17 and 0.90, respectively.
  
  
  CONCLUSIONS
  Subject characteristics strongly influence the PI in clinical studies of hormonal contraceptives. In particular, Hispanic ethnicity, previous pregnancies and no previous use of hormonal contraceptives result in a higher PI.
  
  
  CONCLUSIONS
  PIs from different clinical trials cannot be meaningfully compared unless subject characteristics that have most impact on the PI are similar or are made to be similar statistically as we did here by matching.
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany; Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg/Saar, Germany. Electronic address: christoph.gerlinger@bayer.com.
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.affiliation: Office of Population Research, Princeton University, Princeton, NJ 08544, USA; The Hull York Medical School, Hull HU6 7RX, UK.
authors.forename: James
authors.initials: J
authors.lastname: Trussell
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Mellinger
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Merz
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Marr
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Bannemerschult
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
authors.forename: Ilka
authors.initials: I
authors.lastname: Schellschmidt
authors.affiliation: Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany; Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg/Saar, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
mesh_terms: D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects; D015331:Cohort Studies; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D005060:Europe; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016555:Matched-Pair Analysis; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D009652:Norpregnenes / Q000008:administration & dosage / Q000009:adverse effects; D011247:Pregnancy; D011275:Pregnancy, Unwanted; D011372:Progestins / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D013020:South America; D057968:Transdermal Patch / Q000009:adverse effects; D014481:United States; D055815:Young Adult
chemical_list: D000736:Androstenes; D003271:Contraceptive Agents, Female; D003278:Contraceptives, Oral, Hormonal; D009652:Norpregnenes; D011372:Progestins; C033273:Gestodene; D004997:Ethinyl Estradiol; C023635:dienogest; D004958:Estradiol; D009277:Nandrolone; C035144:drospirenone
keywords: Contraception; Contraceptive failure; Pearl Index; Study population; Subject characteristics