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The European Journal of Contraception & Reproductive Health Care Volume 21, 2016 - Issue 1
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Short Communication

Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Paloma Lobo Abascal *Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, SpainCorrespondence[email protected]
,
Vesna Luzar-StifflerCAIR Center – The House of Statistics, Zagreb, Croatia
,
Silvana GiljanovicMedical Affairs EU, Pliva Croatia, Teva Group, Zagreb, Croatia
,
Brandon HowardTeva Global Medical Affairs, Frazer, PA, USA
,
Herman WeissTeva Global Medical Affairs, Petach Tikva, Israel
&
James TrussellOffice of Population Research, Princeton University, Princeton, NJ, USA
Pages 88-91 | Published online: 26 Jun 2015

References

  • Seasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) [prescribing information]. Horsham, PA: Teva Branded Pharmaceutical Products R & D Inc. 2012.
  • Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) [prescribing information]. North Wales PA: Teva Pharmaceuticals USA, Inc. 2014.
  • European Medicines Agency. Assessment Report: Zoely (nomegestrol/estradiol) Procedure No.: EMEA/H/C/001213. Accessed 4 September 2014 from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001213/WC500115833.pdf.
  • U.S. Food and Drug Administration. Final summary minutes: Advisory Committee for Reproductive Health Drugs meeting. Accessed 1 May 2015 from: http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4274m1.pdf
  • Szarewski A, von Stenglin A, Rybowski S. Women's attitudes towards monthly bleeding: Results of a global population-based survey. Eur J Contracept Reprod Health Care 2012;17:270–83.
  • Vandever MA, Kuehl TJ, Sulak PJ, et al. Evaluation of pituitary-ovarian axis suppression with three oral contraceptive regimens. Contraception 2008;77: 162–70.
  • Anderson FD, Gibbons W, Portman D. Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol. Contraception 2006;73:229–34.
  • European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on clinical investigation of steroid contraceptives in women. Accessed 2 February 2015 from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003349.pdf.
  • Trussell J, Portman D. The creeping Pearl: Why has the rate of contraceptive failure increased in clinical trials of combined hormonal contraceptive pills? Contraception 2013;88:604–10.
  • Kroll R, Seidman L, Ricciotti N, et al. A phase 1, multicentre, open-label study to evaluate ovarian follicular activity and hormone levels with an extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation. Eur J Contracept Reprod Health Care 2014 Dec 19 [Epub ahead of print].

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