To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: First New Class of Oral Birth Control in 10 Years Available in U.S. URL: http://www.pslgroup.com/dg/2273A.htm Doctor's Guide March 27, 1997
MORRIS PLAINS, N.J. -- March 27, 1997 -- Estrostep(R) (norethindrone acetate and ethinyl estradiol tablets, USP) from Parke-Davis offers healthcare providers and women a new approach to low estrogen dosing. Estrostep(R), the first oral contraceptive (OC) in a new class called "Estrophasic(TM)" is now available in the United States. The Estrophasic OC phases in estrogen in gradually increasing doses over the course of a women's cycle. Estrophasic is the first new class of OCs to be marketed in more than 10 years. Estrostep works by providing low, gradually increasing amounts of estrogen (20,30,35 mcg ethinyl estradiol) with a low, constant dose of progestin (one mg norethindrone acetate). Since the earliest days of OCs, side effects such as nausea, break-through bleeding, breast tenderness, and amenorrhea, have been a concern for patients and physicians, especially for women first starting an OC. Recently, a national survey by the Association of Reproductive Health Professionals (ARHP) of current and recent OC users found that side effects were a key reason for women quitting the pill, second only to stopping OC use to become pregnant. Estrostep was found to be well-tolerated in a clinical study involving 1,200 patients (769 receiving Estrostep), with a low overall drop-out rate due to side effects. Each of the following common OC side effects had drop-out rates of less than 1%. Estrogen's role in cycle control is to stabilize the endometrium therby helping to avert irregular shedding and break-through bleeding. In clinical studies, Estrostep demonstrated cycle control comparable to a 30 mcg monophasic OC. "Our theory in developing a graduated estrogen OC was that it would expose women to relatively low doses of estrogen at the beginning of the cycle, and thus, would be well tolerated," explained Leon Speroff, MD, professor of Obstetrics and Gynecology at Oregon Health Sciences University in Portland, and one of the early researchers on this class of OCs. Graduated Estrogen Dosing Monophasic birth control pills contain a constant dose of estrogen and progestin. Triphasics change the dose of progestin throughout the cycle while keeping the estrogen dose constant or increasing then decreasing the estrogen dose. This is the first OC that gradually phases in the estrogen component of the pill in increasing doses. With Estrostep, low doses of estrogen are phased into the woman's body in three graduated steps during the menstrual cycle: 20 micrograms (mcg) of estrogen (ethinyl estradiol) for the first five days, 30 mcg for the next seven days, and 35 mcg for the last nine days, for a total of 21 days. Estrogen and progestin are stopped for the remaining seven days of the cycle, resulting in a woman's monthly menstrual period. The 28-day pill pack will contain seven inactive tablets to help women maintain their regimen. When used as directed, Estrostep is greater than 99% effective in preventing pregnancy, as are all other combination OCs. The most common pill prescribed today contains a constant 35 mcg estrogen dose. Early generation pills contained doses of estrogen as high as 150 mcg. Studies linking high doses of the hormone to adverse effects have resulted in a progressive reduction of estrogen content, leading to today's low-dose pills. In addition to contraception, Estrostep, like all oral contraceptives, may also provide several health benefits including: lower incidence of ovarian cysts, lower incidence of pelvic inflammatory disease, reduced likelihood of developing cancer of the ovaries and cancer of the lining of the uterus, more regular periods, lighter menstrual flow and less menstrual discomfort. However all OCs are also associated with certain side effects. Nausea/vomiting, break-through bleeding and headaches are common. Clinical studies with Estrostep showed that these side effects as well as weight gain each caused fewer then one percent of women to withdraw from therapy. Estrostep was developed by the Parke-Davis division of Warner-Lambert Company, which holds the patent until 2007. Parke-Davis, a division of Warner-Lambert Company, is devoted to discovering, developing, manufacturing and marketing pharmaceutical products. 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