Interest in extended-use contraception to grow
Get ready for a major change to occur in the way birth control pills are prescribed and used with the arrival of Seasonale, the first dedicated extended-regimen oral contraceptive. Shipment of the product, marketed by Barr Laboratories of Pomona, NY, is on its way to retail pharmacy shelves following the Sept. 5, 2003, approval from the Food and Drug Administration (FDA).
While the concept of using pills for more than 21 days at a time is not a new one, the introduction of Seasonale will have the same impact on extended regimen contraception as was seen in the increase in prescription of emergency contraception (EC) following the arrival of dedicated EC pills, reports Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. "The availability of two emergency contraceptive pills with instructions for their use lends credibility to the use of hormones used sparingly as emergency contraceptives since the early 1970s," he remarks. "The formal approval of Seasonale may have an even more dramatic effect, because not only does Seasonale contain the same hormones as five currently available pills: Lo-Ovral (Wyeth-Ayerst, Philadelphia); Levlen (Berlex Laboratories, Montville, NJ); Levora and Lo-Ogestrel (Watson Pharmaceuticals, Corona, CA); and Nordette (King Pharmaceuticals, Bristol, TN), but Seasonale provides these hormones in a completely new regimen."
Look for other companies to develop other forms of extended regimen contraception; researchers are evaluating extended use of the Ortho Evra transdermal contraceptive and the NuvaRing contraceptive vaginal ring. Barr Laboratories plans to explore other forms of extended contraception as well; another of its oral contraceptive products, known as DP3, now is in clinical trials. This extended regimen OC includes levonorgestrel and ethinyl estradiol taken for up to 84 days, followed by seven days of ethinyl estradiol.
Scientists are looking at different uses for extended regimen contraception. Researchers at the Penn State Milton S. Hershey Medical Center in Hershey, PA, are conducting a six-month study designed to examine the effects of a continuous oral contraceptive pill on ovarian and endometrial function.
New research indicates that long-term continuous OC use can be proposed to women with symptomatic endometriosis and menstruation-related pain symptoms.1 The study followed 50 women who had undergone surgery for endometriosis in the previous year and experienced recurrent dysmenorrhea despite cyclic OC use. Participants underwent continuous use of an OC containing ethinyl estradiol (0.02 mg) and desogestrel (0.15 mg) for two years. At final evaluation, 80% said they were satisfied with the treatment.1
As clinicians begin to offer extended regimen contraception to patients, the task at hand will be to explain that for women using hormonal contraceptives, there is no health advantage or necessity for monthly bleeding, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville.
"In addition, we need to help women considering Seasonale, as with women starting any hormonal contraceptive, understand that unscheduled spotting/bleeding is common during the initial months of use," he states. "Over time, unscheduled bleeding declines to levels comparable to conventional 21/7 oral contraceptive use."
Women who use Seasonale should be counseled to expect to have more bleeding or spotting between their menstrual periods than if they were taking an oral contraceptive with a 28-day treatment cycle, states the product literature.2
Explain to women that during the first Seasonale treatment cycle, about one in three women may have 20 or more days of unplanned bleeding or spotting, but this bleeding or spotting tends to decrease during later cycles. Women should not stop taking Seasonale because of the bleeding; if the spotting continues for more than seven consecutive days or if the bleeding is heavy, they should be instructed to call your office.
Because Seasonale users can expect to have fewer periods, its labeling also advises women to consider the possibility that they may be pregnant if they miss any scheduled periods. Be sure to review this point with your patients, advises David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical Center in Norfolk.
Counsel women to consider the possibility of pregnancy if they experience no bleeding on the days that they are taking the white tablets in the Seasonale pill package, state package instructions.1 Tell them to notify your office if they have missed their period or if they have symptoms of pregnancy such as morning sickness or unusual breast tenderness.2
(Editor’s note: If you are a subscriber to Contraceptive Technology Update and have shared your e-mail address with us, you should have received an e-mail on Sept. 8 that gave you the news on Seasonale’s regulatory approval. If you would like to receive future e-mails regarding news events about contraceptives, please contact customer service with your e-mail address. Customer service can be reached at (800) 688-2421 or [email protected]. To obtain more information on Seasonale, see information on audio conference, p. 130.)
References
1. Vercellini P, Frontino G, De Giorgi O, et al. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril 2003; 80:560-563.
2. Barr Laboratories Inc. Patient Product Information. Seasonale. Accessed at www.seasonale.com.
Get ready for a major change to occur in the way birth control pills are prescribed and used with the arrival of Seasonale, the first dedicated extended-regimen oral contraceptive.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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