The Society for Menstrual Cycle Research holds that this use of COCPs does not have sufficient safety studies to justify promotion as a lifestyle choice (as opposed to medical indications), and criticizes what it perceives as negative portrayals of normal menstrual cycles in promotional literature for extended and continuous COCP use.Womens satisfaction with their contraception, compliance in taking the pills on time, and discontinuation rates are not significantly different between traditional and extended cycle regimens. Side effects
With all extended-cycle COCPs, breakthrough bleeding is the most common side effect, although it tends to decrease over time. In a 12-month study of a continuous COCP regimen, 59% of women experienced no bleeding in months six through twelve and 79% of women experienced no bleeding in month twelve. Extended or continuous use of COCPs or other combined hormonal contraceptives carries the same risk of side effects and medical risks as traditional COCP use. Ad campaign
One of the early extended-cycle COCPs, Seasonale, was marketed with the campaign, "Fewer periods. More possibilities." In December 2004, Barr Pharmaceuticals was warned by the FDA concerning these television advertisements. As the warning stated, "By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience." Although clinical studies had proven Seasonale to be effective in preventing pregnancy, the FDA felt the commercial advertisements omitted the common side effects of irregular vaginal bleeding or spotting.
Brands
Seasonale is produced by Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals; Barr Pharmaceuticals also produces the same medicine as a generic called Jolessa. Quasense is the generic version produced by Watson Pharmaceuticals. Seasonale contains 30 micrograms of ethinylestradiol and 150 micrograms of levonorgestrel in each active pill. Seasonale reduces the frequency of menstrual periods from thirteen per year to four per year by changing the regimen of active pills from 21 to 84. Each package has 84 active pills and seven placebo pills to be taken at the end of the active cycle. It was first developed by Barr Pharmaceuticals, in collaboration with Eastern Virginia Medical School, under an agreement. The U.S. Food and Drug Administration (FDA) approved Seasonale in the United States on September 5, 2003. Barr Pharmaceuticals, its manufacturer, claimed at the time of Seasonales approval that it would cost one dollar per pill. Health Canada approved Seasonale in July 2007, and Paladin Labs began distributing it in Canada on January 4, 2008.Seasonique, also produced by Duramed Pharmaceuticals, has active pills and packaging identical to Seasonale, but replaces the placebo week with a low-dosage week of estrogen. Lybrel is produced by Wyeth Pharmaceuticals. It contains 90 µg levonorgestrel and 20 µg ethinylestradiol in each pill, and is designed to be taken continuously with no placebos. The FDA approved Lybrel for human consumption on May 22, 2007. References
Further reading
Elsimar M. Coutinho; Sheldon J. Segal (1999). Is menstruation obsolete?. Oxford: Oxford University Press. ISBN 0-19-513021-9. Susan Rako (2006). The Blessings of the Curse: No More Periods?.