The U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive, ORTHO TRI-CYCLEN(r) LO (norgestimate/ethinyl estradiol) Tablets for the prevention of pregnancy. ORTHO TRI-CYCLEN LO will be available by prescription in the fall.
Like other oral contraceptives, ORTHO TRI-CYCLEN LO, is highly effective when taken correctly. It contains a combination of hormones -- 25 micrograms (mcg) of estrogen and the progestin, norgestimate -- which provides excellent cycle control and tolerability.
ORTHO TRI-CYCLEN LO was developed by Ortho-McNeil Pharmaceutical, Inc., the leader in the U.S. contraceptive market and the maker of ORTHO TRI-CYCLEN(r) (norgestimate/ethinyl estradiol) Tablets, the nation's #1 prescribed birth control pill and the first to be FDA-approved to improve moderate acne and help maintain clearer skin. "ORTHO TRI-CYCLEN LO is an important new option in birth control, and one that I believe women will be excited about," said Ronald T. Burkman, M.D., Bay State Medical Center, Department of Obstetrics and Gynecology, Springfield, Mass. "The distinctive combination of a lower dose of estrogen with the trusted progestin, norgestimate, provides women a new option in birth control that is highly effective and has a favorable side effect profile."
According to Dr. Burkman, many women are unaware of the role that estrogen and progestin play in birth control pills. Both components prevent ovulation and support the endometrium (the lining of a woman's uterus) to provide cycle control and minimize breakthrough bleeding and spotting -- an inconvenient and sometimes embarrassing side effect. Research has shown that these effects may occur more frequently in some pills containing 20 mcg of estrogen.
While all combination birth control pills contain a progestin, ORTHO TRI-CYCLEN LO and ORTHO TRI-CYCLEN contain norgestimate, a progestin with more than 10 years of proven clinical performance. By lowering the levels of serum free testosterone in a woman's body, the profile of norgestimate is associated with low rates of nuisance side effects such as weight gain, acne and facial hair growth. Almost 50% of women who stop using the Pill do so because of side effects often related to the dose and type of hormones in the Pill. ORTHO TRI-CYCLEN LO offers a dose of hormones to provide the contraceptive protection a woman needs with excellent tolerability.
The new, low-dose formulation provides a daily 25 mcg dose of estrogen for 21 days and three different doses of norgestimate (180 mcg daily/days 1-7; 215 mcg daily/days 8-14; 250 mcg daily/days 15-21). The last seven days contain no active ingredients.
ORTHO TRI-CYCLEN LO can be used with the ORTHO PERSONAL PAK Tablet Dispensers, the only collection of fashionably discreet birth control pill packaging. Women may choose from six styles, including two, limited edition compacts created by fashion designer Nicole Miller.
ORTHO TRI-CYCLEN LO Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy and can be a good choice for women 15 or over with mild to moderate acne, who have reached menstruation, are seeking contraception, have no known contraindications to birth control pills, and are unresponsive to topical acne medication.
Oral contraceptives are not for everybody. Most side effects of the Pill are not serious and those that are, occur infrequently. 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're over 35. Women who use oral contraceptives are strongly advised not to smoke. Some studies have reported an increase in the risk of developing breast cancer among women who use oral contraceptives. However, the majority of studies have found no overall increase in this risk. You should talk to your doctor or health care professional about how this risk relates to your use of the Pill. 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.
Ortho-McNeil Pharmaceutical, Inc. is a pioneer and a leader in contraception and women's health care. Ortho-McNeil offers the broadest range of prescription birth control options, including the first transdermal contraceptive patch, nine birth control pills, a leading intrauterine device (IUD) and diaphragms. The company also markets prescription pharmaceutical products in other therapeutic categories, including central nervous system, urology, infectious disease, analgesics and wound healing.
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