Healthcare Industry News:  Estradiol Transdermal 


 News Release - May 9, 2007

Data Show Low Incidence of Breakthrough Bleeding With ORTHO TRI-CYCLEN(R) LO In a Broad Range of Women

SAN DIEGO, May 9 (HSMN NewsFeed) -- Use of the widely used birth control pill, ORTHO TRI-CYCLEN® LO (norgestimate/ethinyl estradiol) Tablets, resulted in significantly lower rates of breakthrough bleeding and spotting in a broad range of women compared to another low-dose combination birth control pill, according to data presented today at the 55th Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG).(1)

This analysis compared the breakthrough bleeding and spotting profiles of two low-dose birth control pills, containing either 25 mcg or 20 mcg of ethinyl estradiol and differing progestins, in women across a range of ages and weights.

Breakthrough bleeding and spotting, which refers to irregular or unexpected bleeding between periods, is a side effect associated with the use of birth control pills, especially low-dose pills, and is the leading cause of dissatisfaction and discontinuation of oral contraceptive use. It most commonly occurs in the first few months of taking a new pill, and often ceases once the body adjusts to the hormonal dosage.

The findings are based on a retrospective analysis of data from a randomized clinical trial evaluating the safety and efficacy of ORTHO TRI- CYCLEN LO compared to Loestrin® Fe 1/20 (norethindrone acetate/20 mcg ethinyl estradiol) tablets. The study evaluated the incidence of breakthrough bleeding and spotting in 1,506 women using ORTHO TRI-CYCLEN LO versus 1,057 women using norethindrone acetate/20 mcg ethinyl estradiol tablets for up to 13 continuous menstrual cycles.

All women were between the ages of 18 and 45 and weighed between 90 and 240 pounds. Women were stratified by age and by weight, and all groups were analyzed to determine the incidence of breakthrough bleeding and spotting by cycle. Cycle six data were presented as representative data for this analysis.

Based on this study analysis, a lower incidence of breakthrough bleeding and spotting was observed for women using ORTHO TRI-CYCLEN LO versus norethindrone acetate/ethinyl estradiol regardless of age or weight.

ORTHO TRI-CYCLEN® LO (norgestimate/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception. It is a low-dose, tri-phasic hormonal birth control pill that provides high efficacy in pregnancy prevention with a low incidence of common side effects.

Loestrin Fe 1/20 is marketed by Barr Pharmaceuticals, Inc.

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 in woman 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.

Please see the full U.S. Prescribing Information at

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, celebrating 75 years of partnering with women. Ortho Women's Health & Urology is committed to helping people live healthier lives and to meeting the needs of providers and patients with products such as ORTHO EVRA® (norelgestromin/ethinyl Estradiol Transdermal system), ORTHO TRI-CYCLEN® LO (norgestimate/ethinyl estradiol), DITROPAN XL® (oxybutynin chloride), and ELMIRON® (pentosan polysulfate sodium). For more information on these products, birth control, bladder health or general women's health issues, please visit


Media Contacts: Gloria Vanderham, 862-686-0606 (onsite) and 908-927-3756 (office)

Amy Firsching, 908-218-7583 (office)

IR Contacts: Stan Panasewicz, 732-524-2524 or Lesley Fishman, 732-524-3922.

(1) Raymond Moss Hampton, MD; Huabin F. Zhang, MD, MPH; Christopher Barnowski, MD; George J. Wan, PhD, MPH. Bleeding Patterns With Mono- and Triphasic Low-dose Ethinyl Estradiol Combined Oral Contraceptives. Poster presentation at: 55th Annual Clinical Meeting of The American College of Obstetricians and Gynecologists, May 5-9, 2007, San Diego, CA.

Source: Ortho-McNeil Pharmaceutical

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