Bleeding Profile Expert Opinion Videos Weight Data

In a head-to-head clinical trial* on cycle control...

Women on ORTHO TRI-CYCLEN® LO experienced 25% fewer mean days of unscheduled bleeding† overall than those on YAZ®1



Women on ORTHO TRI-CYCLEN® LO reported significantly lower incidence of unscheduled bleeding in Cycles 2 and 3 than those on YAZ®1



Cycle Control Results: ORTHO TRI-CYCLEN® LO vs YAZ®


Ronald T. Burkman, MD

Professor
Department of Obstetrics and Gynecology
Tufts University School of Medicine and Baystate Medical Center
Springfield, MA
Ortho Women's Health & Urology™ Consultant Speaker

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PDF of the clinical poster

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*A 3-cycle, nationwide, open-label clinical study to evaluate cycle control with
  ORTHO TRI-CYCLEN® LO & YAZ® in healthy, sexually active females.

† Unscheduled bleeding is any bleeding or spotting during active pill taking,    excluding days 1-7 of active pills of Cycle 1 and Days 1-4 of active pills of    Cycles 2 or 3 if contiguous with withdrawal bleeding.



YAZ (drospirenone/ethinyl estradiol) is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
    Reference:
  1. Kaunitz AM, Burkman RT, Fisher AC, LaGuardia KD. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol. 2009;114:1205-1212.

In a nationwide 13-cycle head-to-head trial...

Approximately 50% fewer women experienced breakthrough bleeding and spotting on ORTHO TRI-CYCLEN® LO than those on a 20-mcg monophasic comparator*1
Across all age groups, significantly fewer women experienced breakthrough bleeding and spotting on ORTHO TRI-CYCLEN® LO than those on a 20-mcg monophasic comparator*3
Statistical differences in BTB/S occurred in all of the first 6 cycles (P<0.05)1

* A randomized, multicenter, pivotal study comparing the ORTHO TRI-CYCLEN® LO   regimen (n=1723) with 20-mcg monophasic comparator regimen; two-thirds of participants   received study drug for 6 cycles and one-third for 13 cycles.

†Valid on-therapy cycle evaluation.

‡P<0.05 for each timepoint and age group.



Cycle bleeding

Lee P. Shulman, MD, FACOG, FACMG
Professor and Chief
Division of Reproductive Genetics
Chicago, IL
Northwestern University
Ortho Women's Health & Urology™ Consultant Speaker Bureau Member



Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) is a registered trademark of Warner Chilcott.

    References:
  1. Hampton RM, Hampton RM, Short M, Bieber E, et al. Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. Contraception. 2001;63:289-295.
  2. Data on file, Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  3. Hampton RM, Zhang HF, Barnowski C, Wan GJ. Bleeding patterns with mono- and triphasic low-dose ethinyl estradiol combined oral contraceptives. Poster presented at: 55th Annual Meeting of the American College of Obstetricians and Gynecologists; May 5-9, 2007; San Diego, CA.
ORTHO TRI-CYCLEN® LO demonstrates a favorable bleeding profile regardless of weight*1

*A retrospective analysis of 25-mcg triphasic pill phase 3 BTB/S data by weight.1
†Valid on-therapy cycle evaluation.
    Reference:
  1. Hampton RM, Zhang HF, Barnowski C, Wan GJ. Bleeding patterns with mono- and triphasic low-dose ethinyl estradiol combined oral contraceptives. Poster presented at: 55th Annual Meeting of the American College of Obstetricians and Gynecologists; May 5-9, 2007; San Diego, CA.