A multicenter, randomized study of an extended cycle oral contraceptive

F. D. Anderson, Howard Hait, Davis Baldwin, Irwin Kerber, Alfred Moffet, James A. Simon, Karen Kreutner, John Angelo, Suzanne Barbier, Paul Blumenthal, Anthony Chavez, Nancy Cooley, Jay Cooper, Vivien D'Andrea, Thomas Davies, Kyrin Dunston, Edward Durbin, Donald Edger, Robert Feldman, Frederick FingerhutFrances Fisk, Samuel Flannagan, Bill Griffin, Charles Herring, Andrew Kaunitz, Rebecca Knight, James Lackey, Sooji Lee-Rugh, Thomas Littlejohn, James Maly, Phyllis Marx, Marjorie Merod, David Morin, Robert Mucciola, Anjuli Nayak, Robert Nett, Arthur Pitterman, Robert Prout, David Portman, Paul Miller, George Raad, Sidney Rosenblatt, Mark Shepard, John Stoukides, Michael Swor, Timothy Truitt, Wulf Utian, Cheryl Walker

Research output: Contribution to journalArticlepeer-review

240 Scopus citations

Abstract

Objective: To assess the efficacy and safety of Seasonale®, 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle. Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 μg EE/150 μg LNG followed by 7 days of placebo, was effective, safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)89-96
Number of pages8
JournalContraception
Volume68
Issue number2
DOIs
StatePublished - Aug 1 2003

Keywords

  • Cycle control
  • Electronic diary
  • Extended cycle
  • Oral contraceptive
  • Seasonale

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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