About Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)

ORTHO TRI-CYCLEN is an estrogen and progestin combination used to prevent pregnancy. It may also be used to regulate the menstrual cycle, treat symptoms of menopause, or treat other conditions as determined by your doctor.

ORTHO TRI-CYCLEN, introduced in 1992, is the only oral contraceptive cleared in the U.S. for the treatment of moderate acne vulgaris in women 15 years of age or older, who have no known contraindication to oral contraceptive therapy, who desire contraception, who have begun menstruation and who are unresponsive to topical anti-acne medications. It is also indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

There are a variety of health benefits associated with the use of oral contraceptives like ORTHO TRI-CYCLEN, including reduced cramping, increased menstrual regularity and lighter menstrual flow. In addition, the Pill may decrease the incidence of acute pelvic inflammatory disease -- a condition which, left untreated, can cause infertility. Iron-deficiency anemia and ectopic pregnancies may also occur less frequently among Pill users. The Pill does not, however, protect users against sexually transmitted diseases, including HIV.

How It Works

Just like your natural levels of hormones vary throughout your cycle, so do the hormonal doses in ORTHO TRI-CYCLEN, delivering three levels instead of just one. So you get the right amount of hormones throughout your cycle to prevent pregnancy - with a low dose.

As you go through your normal cycle, every 28 days or so, the pituitary gland releases hormones that signal the ovaries to prepare an egg and send it to the uterus-to be fertilized.

However, when you take ORTHO TRI-CYCLEN, which contains two types of hormones (norgestimate and ethinyl estradiol), it inhibits this process from occurring and, as a result, no egg is released. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus. So it's easy for you to prevent pregnancy.

Taking medicine responsibly means more than simply swallowing a pill or applying a cream on your skin. Prescription medicines provide many health benefits, but they are not risk-free. Using medications safely is largely a matter of common sense and caution. With proper use, you can ensure that you get the medicine's full benefits, avoid potential problems, and reduce your chances of having side effects. Your doctor, pharmacist, or other healthcare professionals can help you better understand the benefits and risks about the medicines you are taking.

History

In 1960, the U.S. Food and Drug Administration approved the first oral contraceptives for marketing in the U.S. Ortho Pharmaceutical introduced its first birth control pill in 1963. By 1965, the Pill became the nation's leading method of reversible contraception.

The ensuing decades brought continued pill research, discovery and innovation. While early pill formulations contained up to 100 to 150 micrograms (mcg) of estrogen, later studies confirmed that far less hormone was needed to prevent conception. Pills were introduced in the '60s and '70s by Ortho Pharmaceutical Corporation with decreasing estrogen and progestin levels. In 1973, the Company introduced the first progestin-only pill, which contained 350 mcg of norethindrone with no estrogen component.

The next decade saw further progress. Ortho introduced the first multiphasic pill formulations—called bi-phasics and tri-phasics —in 1982 and 1984, respectively. In these formulations, the level of progestin changes during the monthly reproductive cycles. In the late '80s, further development resulted in the introduction of formulations that contained one-third the original dose of estrogen and one-twentieth the original amount of progestin (.035mg EE (estrogen)) and .5 mg norethindrone (progestin), while still maintaining a 99 percent effectiveness rate.

In the early '90s, the first new progestin in 20 years entered the U.S. market. Norgestimate, a synthetic version of the female hormone progesterone, was introduced by Ortho in a combination pill with a 35 mcg dose of ethinyl estradiol (estrogen), a formulation equally effective in pregnancy prevention.

In 1988, the U.S. Food and Drug Administration recognized several potential noncontraceptive health benefits of pill use, including a decreased incidence of ovarian cancer, endometrial cancer, pelvic inflammatory disease, ovarian cysts, benign breast disease, iron deficiency anemia and dysmenorrhea.

In 1989, an advisory committee to the FDA recognized that the benefits of low-dose oral contraceptive use may outweigh the possible health risks of pill use by healthy, nonsmoking women beyond the age of 40.

In addition to scientific studies related to the Pill, there is also a significant amount of behavioral research of Pill use among American women.This research has shown, for example, that the Pill remains the most popular method of reversible birth control in this country, that it has been used by 80 percent of women at one point during their reproductive lives and that women are now staying on the Pill longer than ever before.

 

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