| 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.
Important Safety Information
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.
About Ortho Women's Health & Urology
Ortho Women's Health & Urology, a division of Ortho-McNeil
Pharmaceutical, Inc., is a leader in the fields of women's
health and urology and is committed to providing patients with
products that help them to live healthier lives. Ortho Women's
Health & Urology, a trusted partner of healthcare professionals,
is committed to meeting the needs of providers and patients
with products such as ORTHO EVRA(R) (norelgestromin/ethinyl
estradiol transdermal system), ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl
estradiol), DITROPAN XL(R) (oxybutynin chloride), and ELMIRON(R)
(pentosan polysulfate sodium). |
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