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®1Women on ORTHO TRI-CYCLEN® LO reported significantly lower incidence of unscheduled bleeding in Cycles 2 and 3 than those
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
Janssen Pharmaceuticals, Inc. Consultant Speaker
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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:
- 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* 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
Janssen Pharmaceuticals, Inc. 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:
- 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.
- Data on file, Ortho-McNeil-Janssen Pharmaceuticals, Inc.
- 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.
*A retrospective analysis of 25-mcg triphasic pill phase 3 BTB/S data by weight.1
†Valid on-therapy cycle evaluation.
- Reference:
- 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.