Studies indicate that irregular bleeding is the most common side effect leading to OC discontinuation.1
    Favorable breakthrough-bleeding profile
  • Just 0.5% of women discontinued ORTHO EVRA® due to bleeding in clinical trials2
  • Similar low rates of breakthrough bleeding and/or spotting (BTB/BTB-S) in both the ORTHO EVRA® group and the ORTHO-CYCLEN® (norgestimate/ethinyl estradiol) group in a randomized, open-label, dose-ranging study3





Study design: Randomized, open-label, parallel group, 4-cycle, multicenter, dosing-range study to identify the dose of  the contraceptive patch that provides ovulation suppression and cycle control and is well tolerated.
    In a separate randomized, open-label, parallel-group trial
  • Breakthrough-bleeding profile similar to a triphasic OC4
  • No statistically significant differences between ORTHO EVRA® and the triphasic OC comparator with respect to BTB at any cycle4
  • Similar low incidence of BTB and amenorrhea§4
  • BTB/BTB-S rates vs a triphasic OC were higher in Cycles 1 and 2 with no significant difference in subsequent cycles4
    Withdrawal bleeding
    In 3 large clinical trials in North America, Europe, and South Africa, 3330 women (ages 18-45) completed 22,155 cycles of ORTHO EVRA® use.
  • Most women started withdrawal bleeding on the fourth day of the drug-free interval
  • Median duration of withdrawal bleeding was 5 to 6 days
  • Including withdrawal flow and BTB/BTB-S, on average, 26% of women per cycle had 7 or more days of bleeding and/or spotting
*Breakthrough bleeding was defined as requiring sanitary protection of more than 1 pad or tampon on any day during the intermenstrual period.
†Statistically significant difference vs ORTHO-CYCLEN®.
‡Cycle 4 had an intentional 1-day delayed start (ie, 8-day hormone-free interval) for both ORTHO-CYCLEN® and ORTHO EVRA®.
§Amenorrhea is defined as 2 consecutive valid cycles without bleeding or spotting.

    References:
  1. Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol. 1998;179:577-582.
  2. Data on file, Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  3. Dittrich R, Parker L, Rosen JB, Shangold G, Creasy GW, Fisher AC, for the Ortho Evra/Evra 001 Study Group. Transdermal contraception: evaluation of three transdermal norelgestromin/ethinyl estradiol doses in a randomized, multicenter, dose-response study. Am J Obstet Gynecol. 2002;186:15-20.
  4. Audet M-C, Moreau M, Koltun WD, et al, for the ORTHO EVRA/EVRA 004 Study Group. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001;285:2347-2354.