Questions and answers about ORTHO TRI-CYCLEN® LO.
  1. Is breakthrough bleeding common with ORTHO TRI-CYCLEN® LO since it is a low-dose OC?
    ORTHO TRI-CYCLEN® LO is an OC with 25 mcg of ethinyl estradiol (EE) that has been found to demonstrate low rates of unexpected bleeding and provide predictable periods when compared with other leading low-dose OCs. In a 3-cycle nationwide study, women taking ORTHO TRI-CYCLEN® LO experienced 25% fewer mean days of unscheduled bleeding than those taking YAZ® and significantly more women reported scheduled bleeding with ORTHO TRI-CYCLEN® LO.1 In a 13-cycle clinical trial comparing ORTHO TRI-CYCLEN® LO to Loestrin® Fe, approximately 50% fewer women experienced breakthrough bleeding and spotting on ORTHO TRI-CYCLEN® LO.2
  2. Doesn't breakthrough bleeding increase with heavier women? What is the cycle control like with heavier ORTHO TRI-CYCLEN® LO users?
    ORTHO TRI-CYCLEN® LO has a favorable bleeding profile regardless of weight.* A retrospective analysis of a clinical trial demonstrated there was no significant difference in BTB/S across weight groups up to 240 lbs with ORTHO TRI-CYCLEN® LO.3
  3. What is the progestin component in ORTHO TRI-CYCLEN® LO?
    Norgestimate is the progestin in ORTHO TRI-CYCLEN® LO. It is a highly selective and efficient progestin that demonstrates high progestational activity with low androgenic activity associated with acne/oily skin, hirsutism, and weight gain.4-6 In vitro studies show norgestimate exhibits high progesterone receptor selectivity and is even more selective than natural progesterone. Since norgestimate is highly selective, only a low dose is needed to achieve the contraceptive efficacy that you want.4

    Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives are strongly advised not to smoke. The Pill does not protect against HIV or sexually transmitted diseases.
  4. How well is ORTHO TRI-CYCLEN® LO tolerated and what is the discontinuation rate?
    ORTHO TRI-CYCLEN® LO is comprised of a well-tolerated combination of
    25 mcg of ethinyl estradiol and norgestimate. It demonstrates a low overall discontinuation rate of 4% due to adverse events.2 Less than 0.1% of users—that's 1 out of 1723 patients—discontinued as a result of weight gain, and less than 1% from bleeding irregularities.†7,8
  5. Is ORTHO TRI-CYCLEN® LO reimbursed by managed care?
    ORTHO TRI-CYCLEN® LO is a widely reimbursed OC and is accepted by more than 80% of managed care formularies. It has the lowest branded co-pay on the majority of managed care plans.8
*A retrospective analysis of 25 mcg triphasic pill Phase 3 BTB/S data by weight.2
†Includes bleeding between menstrual periods, withdrawal bleeding, menstrual disorder, uterine    hemorrhage, menorrhagia, and amenorrhea.

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

YAZ (drospirenone/ethinyl estradiol) is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

    References:
  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;114:1-8.
  2. 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;63:1205-1212.
  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.
  4. Phillips A, Demarest K, Hahn DW, Wong F, McGuire JL. Progestational and androgenic receptor binding affinities and in vivo activities of norgestimate and other progestins. Contraception. 1990;41:339-410.
  5. Phillips A, Hahn DW, McGuire JL. Preclinical evaluation of norgestimate, a progestin with minimal androgenic activity. Am J Obstet Gynecol. 1992;167:1191-1196.
  6. Dickey RP. Managing Contraceptive Pill Patients. 12th ed. New Orleans, LA: Emis Medical Publishers; 2004.
  7. Burkman R, LaGuardia K, Fisher A, Wu S-C, Creasy G. An assessment of ORTHO TRI-CYCLEN® LO on body weight and study discontinuation. Poster presented at: 51st Annual Clinical Meeting of the American College of Obstetricians and Gynecologists; April 26-30, 2003; New Orleans, LA.
  8. Data on file, Ortho-McNeil-Janssen Pharmaceuticals, Inc.