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New Study Shows Women Experience Significantly Less Unscheduled Bleeding With the ORTHO TRI-CYCLEN(R) LO Birth Control Pill Versus Another Pill
Date:5/5/2009

CHICAGO, May 5 /PRNewswire/ -- The birth control pill ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) is associated with fewer mean days of unscheduled bleeding than another popular birth control pill, YAZ(R) (drospirenone/ethinyl estradiol), in healthy, sexually active women, according to a study presented today at the 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG)(1).

Historical reviews have estimated that at least one third of women who start oral contraceptives (OC) discontinue use after one year. According to one nationwide prospective study, side effects were noted as the most common reason for stopping oral contraceptives with bleeding irregularities being the most common side effect noted(2). Furthermore, approximately 80 percent of women who discontinue OCs, but who do not wish to become pregnant, switch to a less effective method, or no method, of birth control(2). In addition, a related study found that among women who called or visited their providers about OC side effects, more than 30 percent complained of breakthrough bleeding(3).

"While unscheduled bleeding has been regarded as a leading cause for discontinuing oral contraceptives, few studies have compared two commonly prescribed oral contraceptives," said Katherine LaGuardia, M.D., director, medical affairs, Ortho Women's Health & Urology(TM). "The results of this first-of-a-kind study lend further support to ORTHO TRI-CYCLEN LO as an effective birth control option for women desiring more reliable and predictable periods."

Study Details(1)

Conducted over three menstrual cycles in 355 healthy, sexually active females, this randomized, open-label study was designed to compare cycle control attained with a 21-day versus a 24-day OC regimen. The OC regimens evaluated were 21-day ORTHO TRI-CYCLEN LO and 24-day YAZ.

The primary endpoint was the subject's total number of unscheduled bleeding days during cycles 1-3. Unscheduled bleeding was defined as vaginal bleeding during active pill days, except days 1-4 of cycle 2 or 3 if adjacent to withdrawal bleeding, and days 1-7 of cycle 1. These days were excluded because they are usually considered part of a woman's normal bleeding with OC use and therefore cannot be considered unscheduled.

The ORTHO TRI-CYCLEN LO group had approximately 1.5 fewer mean days of unscheduled bleeding compared to the YAZ group (4.6 versus 6.1 mean days; P=0.0031), and approximately 25 percent fewer episodes of unscheduled bleeding (1.47 versus 2.01 episodes; P<0.0031).

"The fact that the ORTHO TRI-CYCLEN LO group was shown to be associated with significantly less unscheduled bleeding is a factor that physicians and patients can now consider when selecting a suitable birth control option," said Andrew M. Kaunitz, lead study author and Professor and Associate Chair of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine, Jacksonville.

Significantly fewer subjects in the ORTHO TRI-CYCLEN LO group experienced unscheduled bleeding than in the YAZ group (66.7 percent versus 82.8 percent; P=0.0010).

Both OC regimens were well tolerated; discontinuation due to any adverse event was 1.7 percent in the ORTHO TRI-CYCLEN LO group and 2.3 percent in the YAZ group.

The study was conducted and funded by Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

About ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol)

ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy. This product is available by prescription only.

Important Safety Information

Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks, and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect against HIV or sexually transmitted diseases.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Visit www.thepill.com for full product information.

About Ortho Women's Health & Urology(TM)

Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a leader in the fields of women's health and urology, celebrating more than 75 years of partnering with women. Ortho Women's Health & Urology(TM) is committed to helping people live healthier lives and to meeting the needs of healthcare professionals and patients with products such as ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system) and ELMIRON(R) (pentosan polysulfate sodium). For more information on these products, birth control, bladder health or general women's health issues, please visit www.orthowomenshealth.com.

    Media Contact:
    Amy Firsching
    AFirschi@its.jnj.com
    (908) 218-7583

    References
    (1) Kaunitz AM, Burkman RT, Fisher AC, LaGuardia KD. A randomized clinical
        trial comparing cycle control in a 21-day vs a 24-day oral
        contraceptive (OC) regimen. May 5, 2009.
    (2) Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: A
        prospective evaluation of frequency and reasons. AM J Obstet Gynecol
        1998;179: 577-82.
    (3) Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, Counseling and
        Satisfaction with Oral Contraceptives: A Prospective Evaluation.
        Family Planning Perspectives 1998; 30: 89-104.


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SOURCE Ortho Women's Health & Urology(TM)
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