New Study Shows Women Experience Significantly Less Unscheduled Bleeding With the ORTHO TRI-CYCLEN(R) LO Birth Control Pill Versus An...( The primary endpoint was the subject'...),Health

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 reporte
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