Extended or continuous cycle combined oral contraceptive pills are a packaging of

combined oral contraceptive pill The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. The pill contains two important hormones: proges ...

s (COCPs) that reduce or eliminate the withdrawal bleeding that would occur once every 28 days in traditionally packaged COCPs. It works by reducing the frequency of the pill-free or placebo days. Extended cycle use of COCPs may also be called menstrual suppression, although other hormonal medications or medication delivery systems (hormonal intrauterine devices—IUDs) may also be used to suppress menses. Any brand of combined oral contraceptive pills can be used in an extended or continuous manner by simply discarding the placebo pills; this is most commonly done with monophasic pills in which all of the pills in a package contain the same fixed dosing of a synthetic estrogen and a progestin in each active pill. Other combined hormonal contraceptives (those containing both an

estrogen Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal a ...

and a

progestin A progestogen, also referred to as a progestagen, gestagen, or gestogen, is a type of medication which produces effects similar to those of the natural female sex hormone progesterone in the body. A progestin is a '' synthetic'' progestogen. Pro ...

) may also be used in an extended or continuous cycle. For example, the

NuvaRing Ethinylestradiol/etonogestrel, sold under the brand names NuvaRing among others, is a hormonal vaginal ring used for birth control and to improve menstrual symptoms. It contains ethinylestradiol, an estrogen, and etonogestrel, a progestin. It ...

vaginal ring and the contraceptive patch have been studied for extended cycle use, and the monthly

combined injectable contraceptive Combined injectable contraceptives (CICs) are a form of hormonal birth control for women. They consist of monthly injections of combined formulations containing an estrogen and a progestin to prevent pregnancy. CICs are different from progesto ...

may similarly eliminate bleeding.

History

Contraception mean prevention of reproduction by artificial means. Before the advent of modern contraceptives, reproductive age women spent most of their time either pregnant or nursing. In modern Western society, women typically have about 450 periods during their lives, as compared to about 160 formerly. Although it was evident that the pill could be used to suppress

menstruation Menstruation (also known as a period, among other colloquial terms) is the regular discharge of blood and mucosal tissue from the inner lining of the uterus through the vagina. The menstrual cycle is characterized by the rise and fall of ...

for arbitrary lengths of time, the original regimen was designed to produce withdrawal bleeding every four weeks to mimic the menstrual cycle. There are 3 types of oral contraceptive pills - combined estrogen-progesterone, progesterone-only, and continuous or extended use pill.

Usage

When a woman takes

COCP The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. The pill contains two important hormones: progesti ...

, the hormones in the pills prevent both ovulation and shedding of the

endometrium The endometrium is the inner epithelial layer, along with its mucous membrane, of the mammalian uterus. It has a basal layer and a functional layer: the basal layer contains stem cells which regenerate the functional layer. The functional lay ...

(

). Traditionally, COCPs are packaged with 21 active (hormone-containing) pills and 7

placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...

pills. During the week of placebo pills, withdrawal bleeding occurs and simulates an average 28-day

menstrual cycle The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of eg ...

. The placebo pills are not required for pregnancy protection, and with any monophasic COCP the placebo pills may be discarded, and the next pack of active pills may be started 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. (Monophasic pills offer the same dose of estrogen and progestogen whereas multiphasic pills have varying doses from day to day; see formulations for details.) Recently, several pharmaceutical companies have gained FDA approval to package COCPs for the intended use of reducing the frequency of or eliminating withdrawal bleeding. The use of COCP is dependent on desirable effects and risk of adverse events with progestin component and dose of estrogen and progesti
component
* Estrogen component: Estradiol, Ethinylestradiol, or Estetrol * First-generation progestin: Norethindrone acetate, Ethynodiol diacetate, Lynestrenol, Norethynodrel * Second generation progestin: Levonorgestrel,dl-Norgestrel * Third generation progestin: Norgestimate, Gestodene, Desogestrel * Unclassified progestin: Drospirenone, Cyproterone acetate

Clinical indications

Extended or continuous use of COCPs has been used for many years to treat

endometriosis Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grow outside the uterus. Most often this is on the ovaries, ...

dysmenorrhea Dysmenorrhea, also known as period pain, painful periods or menstrual cramps, is pain during menstruation. Its usual onset occurs around the time that menstruation begins. Symptoms typically last less than three days. The pain is usually in the ...

, 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. FDA has also formally approved combined pills for acne for specific brands. Oral Contraceptive Pills are also effective in Hidradenitis Suppurativa. There is also limited evidence for benefit of Combined oral contraceptive pill (OCP) as treatment for primary dysmenorrhoea. The evidence from four RCTs is that combined OCPs with medium dose oestrogen and 1st/2nd generation progestogens are more effective than placebo, however the studies were small,

Side effects

With all extended-cycle COCPs,

breakthrough bleeding Intermenstrual bleeding, previously known as metrorrhagia, is uterine bleeding at irregular intervals, particularly between the expected menstrual periods. It is a cause of vaginal bleeding. In some women, menstrual spotting between periods occur ...

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 In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...

and medical risks as traditional COCP use. Pill Failure can happen with contraceptive pills and inadvertent pregnancies happen. Use of oral contraceptive can impair muscle gains in young women. The metabolic impact of oral contraceptives are significant and contraceptive pills can increase the risk of heart attacks. Many preclinical and clinical studies reveal that changes in lipoprotein metabolism are a major contributing factor to atherosclerosis. There was also reported drug interactions between non-rifamycin antibiotics and hormonal contraception but it was not confirmed in a systematic review.

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 was a global specialty and generic drug manufacturer with operations in 30 countries. Approximately 75% of the company's revenues were from the sale of generic drugs, including 18% of sales which were from the sale of oral co ...

; 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 Ethinylestradiol (EE) is an estrogen medication which is used widely in birth control pills in combination with progestins. In the past, EE was widely used for various indications such as the treatment of menopausal symptoms, gynecological dis ...

and 150 micrograms of

levonorgestrel Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand name Plan B One-Step amon ...

in each active pill. Seasonale reduces the frequency of

menstrual periods The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of ...

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

pills to be taken at the end of the active cycle. It was first developed by

, in collaboration with

Eastern Virginia Medical School Eastern Virginia Medical School (EVMS) is a public medical school in Norfolk, Virginia Norfolk ( ) is an independent city in the Commonwealth of Virginia in the United States. Incorporated in 1705, it had a population of 238,005 at the 20 ...

, under an agreement. The U.S. Food and Drug Administration (FDA) approved Seasonale in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five ma ...

on September 5, 2003. Barr Pharmaceuticals, its manufacturer, claimed at the time of Seasonale's approval that it would cost one dollar per pill. Health Canada approved Seasonale in July 2007, and Paladin Labs began distributing it in

Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tota ...

on January 4, 2008.Magnan, Michelle, 2007-07-06
Health Canada approves Seasonale
''Calgary Herald''. ''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 Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...

. It contains 90 µg

and 20 µg

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

External links

Lybrel official site

Seasonale and Seasonique official site

Pro-extended cycle COCP site by Leslie Miller, M.D.
{{DEFAULTSORT:Extended Cycle Combined Hormonal Contraceptive Hormonal contraception Human female endocrine system Wyeth brands Pfizer brands