The popular birth control pill, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) Tablets, is not associated with an increased risk of pregnancy in heavier women, according to findings(1) presented today at the 54th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).

Previous research suggested that higher weight or body mass index (BMI) may compromise the efficacy of birth control pills leading to a greater number of unintended pregnancies.(2,3) This analysis evaluates the risk of pregnancy in heavier women using ORTHO TRI-CYCLEN LO.

"A significant number of women with a wide range of weights and BMIs were included in this analysis, creating a rich source of data to evaluate the association between body weight and efficacy," said Dr. Katherine LaGuardia, director, medical affairs, Ortho Women's Health & Urology. "These results reinforce ORTHO TRI-CYCLEN LO as an effective birth control option for women in a broad range of body weights."

Study Details

The report is based on a retrospective analysis of ORTHO TRI-CYCLEN LO Phase III efficacy data to determine the association of pregnancies with body weight and BMI, a standard measure of weight-for-height. The data were from 1,673 ORTHO TRI-CYCLEN LO users, weighing from 90 to 240 pounds, for 11,003 use cycles.

Investigators found that a total of 20 pregnancies occurred - 14 likely due to "method failure" (eg, the Pill did not work) and six due to failure on the part of the individual (eg, forgetting to take the Pill). This translated into a total pregnancy probability of 1.9 percent and a probability of failure of the Pill of 1.5 percent.

The probability of total and method-failure pregnancies was the same across different body weights. ORTHO TRI-CYCLEN LO users weighing 155 lbs. or more (n=435) did not experience significantly higher pregnancy risk than those less than 155 lbs. with either method-failure pregnancies (relative risk 1.03, p=0.95) or total pregnancies (relative risk 1.42, p=0.46). The results were the same when other weight criteria (median weight of 139 lbs. and over vs. less than 139 lbs., over 175 lbs. vs. less than or equal to 175 lbs., and 198 lbs. and over vs. less than 198 lbs.) and BMI criteria (25 and over vs. less than 25) were applied. The study was conducted and funded by Ortho Women's Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc.

About ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.