What is/are Seasonale?
Extended cycle combined oral contraceptive pills are COCPs packaged to reduce or eliminate the withdrawal bleeding that occurs once every 28 days in traditionally packaged COCPs. Extended cycle use of COCPs may also be called menstrual suppression.
Other combined hormonal contraceptives (those containing both an estrogen and a progestogen) may also be used in an extended or continuous cycle. For example, the NuvaRing vaginal ring and the contraceptive patch have been studied for extended cycle use, and the monthly combined injectable contraceptive may similarly eliminate bleeding.
When a woman takes COCPs (combined oral contraceptive pills), the hormones in the pills prevent both ovulation and shedding of the endometrium (menstruation). Traditionally, COCPs are packaged with 21 active (hormone-containing) pills and 7 placebo pills. During the week of placebo pills, withdrawal bleeding occurs and simulates an average 28-day menstrual cycle. The placebo pills are not required for pregnancy protection, and with any monophasic COCP the placebo pills may be skipped (going straight to the next pack of active pills) to prevent the withdrawal bleeding. With bi- and tri-phasic pills, skipping the placebo week results in a sudden change in hormone levels, which may cause irregular spotting or flow.
Recently, several pharmaceutical companies have gained FDA approval to package COCPs for the intended use of reducing the frequency of or completely eliminating withdrawal bleeding.
Extended or continuous use of COCPs has been used for many years to treat endometriosis, dysmenorrhea, and menstruation-associated symptoms. Some studies have suggested that women who experience premenstrual-type symptoms during the placebo (hormone-free) week of traditionally packaged COCPs may experience significantly fewer symptoms when placed on extended cycle COCP regimens.
More recently, personal preference to avoid menstruation has also become a common reason for use. Personal preference is the most common reason extended cycle or continuous use COCPs are prescribed to adolescents. 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.
Women's satisfaction with their contraception, compliance in taking the pills on time, and discontinuation rates are not significantly different between traditional and extended cycle regimens.
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.
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.
This article uses material from the Wikipedia article Seasonale, which is released under the Creative Commons Attribution-Share-Alike License 3.0.