Contraception
Volume 81, Issue 1 , Pages 41-48 , January 2010

The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol

  • Robin Kroll

      Affiliations

    • Women's Clinical Research Center, Seattle, WA 98105, USA
  • ,
  • Kathleen Z. Reape

      Affiliations

    • Duramed Research, Inc., Bala Cynwyd, PA 19004, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 610 747 2600.
  • ,
  • Marya Margolis

      Affiliations

    • Duramed Research, Inc., Bala Cynwyd, PA 19004, USA

Received 20 March 2009 ,Revised 7 July 2009 ,Accepted 9 July 2009.

References 

  1. Gerstman BB, Gross TP, Kennedy DL, Bennett RC, Tomita DK, Stadel BV. Trends in the content and use of oral contraceptives in the United States, 1964–88. Am J Public Health. 1991;81:90–96
  2. Speroff L, DeCherney A. Evaluation of a new generation of oral contraceptives. The Advisory Board for the New Progestins. Obstet Gynecol. 1993;81:1034–1047
  3. Spitzer WO, Lewis MA, Heinemann LA, Thorogood M, MacRae KD. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ. 1996;312:83–88
  4. WHO Collaborative Study of Cardiovascular Diseases and Steroid Hormone Contraception. Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. Lancet. 1995;346:1575–1582
  5. Gallo MF, Nanda K, Grimes DA, Schulz KF. Twenty micrograms vs. >20 mcg estrogen oral contraceptives for contraception: systematic review of randomized controlled trials. Contraception. 2005;71:162–169
  6. Fauser BCJM, van Heusden A. Manipulation of human ovarian function: physiological concepts and clinical consequences. Endocr Rev. 1997;18:71–106
  7. Killick SR, Fitzgerald C, Davis A. Ovarian activity in women taking an oral contraceptive containing 20 mcg ethinyl estradiol and 150 mcg desogestrel: effects of low estrogen doses during the hormone-free interval. Am J Obstet Gynecol. 1998;179:S18–S24
  8. Spona J, Feichtinger W, Kindermann C, Wunsch C, Brill K. Inhibition of ovulation by an oral contraceptive containing 100 micrograms levonorgestrel in combination with 20 micrograms ethinylestradiol. Contraception. 1996;54:299–304
  9. Schlaff WD, Lynch AM, Hughes HD, Cedars MI, Smith DL. Manipulation of the pill-free interval in oral contraceptive pill users: the effect on follicular suppression. Am J Obstet Gynecol. 2004;190:943–951
  10. Endrikat J, Gerlinger C, Plettig K, et al. A meta-analysis on the correlation between ovarian activity and the incidence of intermenstrual bleeding during low-dose oral contraceptive use. Gynecol Endocrinol. 2003;17:107–114
  11. Reape KZ, DiLiberti CE, Hendy CH, Volpe EJ. Effects on serum hormone levels of low-dose estrogen in place of placebo during the hormone-free interval of an oral contraceptive. Contraception. 2008;77:34–39
  12. Vandever MA, Kuehl TJ, Sulak PJ, et al. Evaluation of pituitary–ovarian axis suppression with three oral contraceptive regimens. Contraception. 2008;77:162–170
  13. Klipping C, Duijkers I, Trummer D, Marr J. Suppression of ovarian activity with a drospirenone-containing oral contraceptive in a 24/4 regimen. Contraception. 2008;78:16–25
  14. Bachmann G, Sulak PJ, Sampson-Landers C, Benda N, Marr J. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception. 2004;70:191–198
  15. Nakajima ST, Archer DF, Ellman H. Efficacy and safety of a new 24-day oral contraceptive regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin 24 Fe). Contraception. 2007;75:16–22
  16. Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: Phase 3 study results. Contraception. 2006;74:439–445
  17. Ortho Tri Cyclen® Lo . Current US Prescribing Information. New Jersey: Ortho-McNeil Pharmaceuticals, Inc.; 2004;
  18. FDA Advisory Committee for Reproductive Health Drugs . Final summary minutes. January 23–24, 2007. http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4274t1-part1.pdfAccessed March 20, 2009
  19. Holt VL, Scholes D, Wicklund KG, Cushing-Haugen KL, Daling JR. Body mass index, weight, and oral contraceptive failure risk. Obstet Gynecol. 2005;105:46–52
  20. Holt VL, Cushing-Haugen KL, Daling JR. Body weight and risk of oral contraceptive failure. Obstet Gynecol. 2002;99:820–827
  21. Brunner LR, Hogue CJ. The role of body weight in oral contraceptive failure: results from the 1995 National Survey of Family Growth. Ann Epidemiol. 2005;15:492–499
  22. Brunner Huber LR, Toth JL. Obesity and oral contraceptive failure: findings from the 2002 National Survey of Family Growth. Am J of Epidemiol. 2007;166:1306–1311
  23. Brunner Huber LR, Hogue CJ, Stein AD, Drews C, Zieman M. Body mass index and risk for oral contraceptive failure: a case-cohort study in South Carolina. Ann Epidemiol. 2006;16:637–643
  24. LaGuardia KD, Shangold G, Fisher A, Friedman A, Kafrissen M. Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol. Contraception. 2003;67:431–437
  25. Anderson FD, Feldman R, Reape KZ. Endometrial effects of a 91-day extended regimen oral contraceptive with low-dose estrogen in place of placebo. Contraception. 2008;77:91–96

 This study was funded by Duramed Pharmaceuticals, Inc. Drs. Reape and Margolis are full-time employees of Duramed Research, Inc.

PII: S0010-7824(09)00348-5

doi: 10.1016/j.contraception.2009.07.003

Contraception
Volume 81, Issue 1 , Pages 41-48 , January 2010