Contraception
Volume 74, Issue 6 , Pages 439-445 , December 2006

Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results

Data contained in this report were presented at the annual meeting of the American Society for Reproductive Medicine, Montreal, Canada, October 2005.

  • David F. Archer

      Affiliations

    • CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA 23507, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 757 446 7444; fax: +1 757 446 8998.
    • ,
  • Jeffrey T. Jensen

      Affiliations

    • Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR 97239, USA
    • ,
  • Julia V. Johnson

      Affiliations

    • Department of Obstetrics and Gynecology, University of Vermont College of Medicine, Burlington, VT 05405, USA
    • ,
  • Hannah Borisute

      Affiliations

    • Women's Health, Clinical Research/ Development, Wyeth Research, Collegeville, PA 19426, USA
    • ,
  • Gary S. Grubb

      Affiliations

    • Women's Health, Clinical Research/ Development, Wyeth Research, Collegeville, PA 19426, USA
    • ,
  • Ginger D. Constantine

      Affiliations

    • Women's Health, Clinical Research/ Development, Wyeth Research, Collegeville, PA 19426, USA

Received 30 March 2006 ,Revised 12 July 2006 ,Accepted 12 July 2006.

References 

  1. den Tonkelaar I, Oddens BJ. Preferred frequency and characteristics of menstrual bleeding in relation to reproductive status, oral contraceptive use, and hormone replacement therapy use. Contraception. 1999;59:357–362
  2. Andrist LC, Arias RD, Nucatola D, et al. Women's and providers' attitudes toward menstrual suppression with extended use of oral contraceptives. Contraception. 2004;70:359–363
  3. Glasier AF, Smith KB, van der Spuy ZM, et al. Amenorrhea associated with contraception—an international study on acceptability. Contraception. 2003;67:1–8
  4. Sulak PJ, Cressman BE, Waldrop E, Holleman S, Kuehl TJ. Extending the duration of active oral contraceptive pills to manage hormone withdrawal symptoms. Obstet Gynecol. 1997;89:179–183
  5. Sulak PJ, Kuehl TJ, Ortiz M, Shull BL. Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms. Am J Obstet Gynecol. 2002;186:1142–1149
  6. Shakespeare J, Neve E, Hodder K. Is norethisterone a lifestyle drug? Results of database analysis. BMJ. 2000;320:291
  7. Anderson FD, Hait H the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89–96
  8. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653–661
  9. Archer DF, Kovalevsky G, Ballagh S, Grubb GS. Effect on ovarian activity of a continuous-use regimen of oral levonorgestrel/ethinyl estradiol. Fertil Steril. 2005;84(Suppl.):S24;[Abstract]
  10. Belsey EM. Menstrual bleeding patterns in untreated women and with long-acting methods of contraception. Task Force on Long-Acting Systemic Agents for Fertility Regulation. Adv Contracept. 1991;7:257–270
  11. Archer DF, Maheux R, DelConte A, O'Brien FB and the North American Levonorgestrel Study Group (NALSG). Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse®). Am J Obstet Gynecol. 1999;181(Suppl.):S39–S44
  12. Teichmann AT, Kluft C, Grubb G, Constantine G, Spielmann D. Comparative trial of continuous-use and 21-day cyclic levonorgestrel and ethinyl estradiol oral contraceptive. Obstet Gynecol. 2006;107(Suppl.):12S;[Abstract]
  13. Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996;54:71–77
  14. Edelman AB, Gallo MF, Jensen JT, Nichols MD, Schulz KF, Grimes DA. Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2005;CD004695;[Review]

☆ This study (ClinicalTrials.gov; NCT00245921) was supported by a grant from Wyeth Research (Collegeville, PA). Drs. David F. Archer, Jeffrey T. Jensen and Julia V. Johnson were investigators for this study and received research funding from Wyeth Research. Other sources of research funding and/or financial relationships include the following: Agile Therapeutics, Berlex, Genentech, Warner Chilcott, Lilly, Novo Nordisk, Ortho-McNeil, Organon International, Solvay Pharmaceuticals, Barr Laboratories, Duramed Pharmaceuticals, Johnson & Johnson and Wyeth for Dr. Archer; Berlex, Warner Chilcott, Pfizer, Organon International and Barr Laboratories for Dr. Jensen; and Berlex, Novo Nordisk, Pharmacia, Procter & Gamble for Dr. Johnson. Drs. Hannah Borisute, Gary S. Grubb and Ginger D. Constantine are employees of Wyeth Research. Other financial affiliations are Merck, Teva and Johnson & Johnson for Dr. Borisute; and Johnson & Johnson for Dr. Grubb. Dr. Constantine has no financial affiliations.

PII: S0010-7824(06)00310-6

doi: 10.1016/j.contraception.2006.07.005

Contraception
Volume 74, Issue 6 , Pages 439-445 , December 2006

Article Tools

* Image Usage & Resolution