Most women would prefer having fewer menstrual periods and a number of them are interested in an effective form of birth control. A new oral contraceptive, Quartette™, manufactured by Teva Pharmaceutical Industries Ltd., received Food and Drug Administration (FDA) on March 29. According to the manufacturer, the contraceptive represents the next the generation of extended regimen oral contraceptives to be approved by the FDA. Some women experience annoying breakthrough bleeding with birth control pills, particularly the extended regimen type; however, Teva notes that Quartette was designed to minimize that problem.
The estrogen in Quartette increases at specific points and provides four short light periods a year. During the 91-day oral regimen, the dose of estrogen increases at three distinct points during the first 84 days and the amount of progestin remains consistent, followed by seven days of 10 μg ethinyl estradiol. “Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens,” explained James A. Simon, M.D., a clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine. He added, “Breakthrough bleeding decreases over time, which might help encourage patient adherence.”
The FDA approval was based on a development program that included results from Phase I, Phase II, and Phase III clinical trials designed to evaluate the safety and efficacy of the medication. The Phase III clinical trial comprised more than 3,000 women. It found that Quartette was 97%t effective at preventing pregnancy. Adverse reactions occurred in about 2% of the women. They included headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea (painful menses), weight gain, mood changes, anxiety/panic attack, breast pain and migraines. These side-effects are comparable to those experienced by women who take a monthly regimen of birth control pills. The primary clinical trial that evaluated the efficacy of Quartette also assessed breakthrough bleeding. It found that breakthrough bleeding and unscheduled spotting decreased over successive 91 day cycles.
Quartette is “a uniquely differentiated product and is based on Teva’s research into when breakthrough bleeding is most likely to occur with these regimens,” explained Jill DeSimone, senior vice president & general manager, Global Teva Women’s Health. She added, “Quartette is the newest product in our global women’s health franchise and is an example of our dedication to providing a variety of contraceptive and family planning options that fit women’s lifestyles.”
As with other hormonal contraceptives, smokers are at increased risk for complications. Teva advises that women who smoke should not use Quartette if they are over 35 years old. Smoking increases the risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes one smokes. You should not take the pill if you have blood clots, certain cancers, a history of heart attack or stroke, undiagnosed abnormal bleeding, or may be pregnant.
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