Seasonale
Encyclopedia
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.
Seasonale 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 Seasonale's approval that it would cost one dollar per pill. Seasonale is one of Barr Pharmaceuticals' 22 oral contraceptive products. Health Canada
approved Seasonale in July 2007, and Paladin Labs began distributing it in Canada
on January 4, 2008.
The FDA approved Lybrel for human consumption on May 22, 2007. Lybrel is currently available at pharmacies by prescription only.
(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.
, 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.
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.
There is no available data at this time concerning the long term effects of menstrual suppression on a woman's overall health. There exists concern in the medical field that increasing the amount of hormones typically taken by a woman may have an adverse effect on her long term health, but there is no data to confirm or disprove this.
; 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.
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 mcg levonorgestrel
and 20 mcg ethinyl estradiol in each pill, and is designed to be taken continuously with no placebos.
Other combined hormonal contraceptives (those containing both an estrogen
Estrogen
Estrogens , oestrogens , or œstrogens, are a group of compounds named for their importance in the estrous cycle of humans and other animals. They are the primary female sex hormones. Natural estrogens are steroid hormones, while some synthetic ones are non-steroidal...
and a progestogen) may also be used in an extended or continuous cycle. For example, the NuvaRing
NuvaRing
NuvaRing is the trade name for a combined hormonal contraceptive vaginal ring manufactured by Merck that is available by prescription...
vaginal ring and the contraceptive patch
Contraceptive patch
A contraceptive patch is a transdermal patch applied to the skin that releases synthetic estrogen and progestin hormones to prevent pregnancy. They have been shown to be as effective as the combined oral contraceptive pill with perfect use, and the patch may be more effective in typical use.The...
have been studied for extended cycle use, and the monthly combined injectable contraceptive
Combined injectable contraceptive
Combined injectable contraceptive monthly injection of progesterone and estradiol taken to inhibit fertility. Brand names include Cyclofem, Novafem, Mesigyna, Lunelle and Cyclo-Provera....
may similarly eliminate bleeding.
History
Although it was evident that the pill could be used to suppress menstruation for arbitrary lengths of time, the original regimen was designed to produce withdrawal bleeding every four weeks to mimic the menstrual cycle.Seasonale was first developed by Barr Pharmaceuticals
Barr Pharmaceuticals
Barr Pharmaceuticals was a global specialty pharmaceutical company that operated in more than 30 countries worldwide. Barr were engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.-History:Barr...
, in collaboration with Eastern Virginia Medical School
Eastern Virginia Medical School
Eastern Virginia Medical School commonly referred to as EVMS, in Norfolk, Virginia is a public-private medical school founded by the citizens of Hampton Roads, Virginia...
, under an agreement. The U.S. Food and Drug Administration (FDA) approved Seasonale in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
on September 5, 2003. Barr Pharmaceuticals, its manufacturer, claimed at the time of Seasonale's approval that it would cost one dollar per pill. Seasonale is one of Barr Pharmaceuticals' 22 oral contraceptive products. Health Canada
Health Canada
Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...
approved Seasonale in July 2007, and Paladin Labs began distributing it in Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
on January 4, 2008.
The FDA approved Lybrel for human consumption on May 22, 2007. Lybrel is currently available at pharmacies by prescription only.
Usage
When a woman takes COCPs (combined oral contraceptive pills), the hormones in the pills prevent both ovulation and shedding of the endometriumEndometrium
-Function:The endometrium is the innermost glandular layer and functions as a lining for the uterus, preventing adhesions between the opposed walls of the myometrium, thereby maintaining the patency of the uterine cavity. During the menstrual cycle or estrous cycle, the endometrium grows to a...
(menstruation
Menstruation
Menstruation is the shedding of the uterine lining . It occurs on a regular basis in sexually reproductive-age females of certain mammal species. This article focuses on human menstruation.-Overview:...
). Traditionally, COCPs are packaged with 21 active (hormone-containing) pills and 7 placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
pills. During the week of placebo pills, withdrawal bleeding occurs and simulates an average 28-day menstrual cycle
Menstrual cycle
The menstrual cycle is the scientific term for the physiological changes that can occur in fertile women for the purpose of sexual reproduction. This article focuses on the human 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.
Clinical indications
Extended or continuous use of COCPs has been used for many years to treat endometriosisEndometriosis
Endometriosis is a gynecological medical condition in which cells from the lining of the uterus appear and flourish outside the uterine cavity, most commonly on the ovaries. The uterine cavity is lined by endometrial cells, which are under the influence of female hormones...
, dysmenorrhea
Dysmenorrhea
Dysmenorrhea is a gynecological medical condition of pain during menstruation that interferes with daily activities, as defined by ACOG and others. Still, dysmenorrhea is often defined simply as menstrual pain, or at least menstrual pain that is excessive...
, 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.
Side effects
With all extended-cycle COCPs, breakthrough bleedingBreakthrough bleeding
Breakthrough bleeding is an abnormal uterine bleeding that occurs between menstrual periods, especially due to irregular sloughing of the endometrium in women on combined oral contraceptives...
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.
There is no available data at this time concerning the long term effects of menstrual suppression on a woman's overall health. There exists concern in the medical field that increasing the amount of hormones typically taken by a woman may have an adverse effect on her long term health, but there is no data to confirm or disprove this.
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 PharmaceuticalsBarr Pharmaceuticals
Barr Pharmaceuticals was a global specialty pharmaceutical company that operated in more than 30 countries worldwide. Barr were engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.-History:Barr...
; Barr Pharmaceuticals also produces the same medicine as a generic called Jolessa. Quasense is the generic version produced by Watson Pharmaceuticals
Watson Pharmaceuticals
Watson Pharmaceuticals, Incorporated is the 5th largest pharmaceutical company in the United States based on number of prescriptions dispensed...
. Seasonale contains 30 micrograms of ethinylestradiol
Ethinylestradiol
Ethynylestradiol , also ethynyl estradiol , is a derivative of estradiol. Ethynyl estradiol is an orally bio-active estrogen used in almost all modern formulations of combined oral contraceptive pills...
and 150 micrograms of levonorgestrel
Levonorgestrel
Levonorgestrel is a second generation synthetic progestogen used as an active ingredient in some hormonal contraceptives.-Chemistry:...
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
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
pills to be taken at the end of the active cycle.
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 mcg levonorgestrel
Levonorgestrel
Levonorgestrel is a second generation synthetic progestogen used as an active ingredient in some hormonal contraceptives.-Chemistry:...
and 20 mcg ethinyl estradiol in each pill, and is designed to be taken continuously with no placebos.