Extended cycle combined hormonal contraceptive

Extended cycle combined hormonal contraceptives
Background
TypeHormonal
First use1993 (first randomized study)[1]
Pregnancy rates (first year)
Perfect use?
Typical use0.9%
Usage
Duration effectvaries
ReversibilityYes
User remindersvaries
Advantages and disadvantages
STI protectionNo
PeriodsEliminates or reduces frequency
BenefitsReduce menstruation related symptoms, reduce risk of anemia

Extended or continuous cycle combined oral contraceptive pills are a packaging of combined oral contraceptive pills (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,[2] 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.[3]

Other combined hormonal contraceptives (those containing both an estrogen and a progestin) may also be used in an extended or continuous cycle. For example, the NuvaRing vaginal ring[4] and the contraceptive patch[5] have been studied for extended cycle use, and the monthly combined injectable contraceptive may similarly eliminate bleeding.[6]

History

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.[7]

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.[8]

Usage

When a woman takes COCP, 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 discarded, and the next pack of active pills may be started to prevent the withdrawal bleeding.[9] 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 completely eliminating withdrawal bleeding.

Clinical indications

Extended or continuous use of COCPs has been used for many years to treat endometriosis, dysmenorrhea, and menstruation-associated symptoms.[10] 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.[11]

More recently, personal preference to avoid menstruation has also become a common reason for use.[10] Personal preference is the most common reason extended cycle or continuous use COCPs are prescribed to adolescents.[12] 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.[13]

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.[10]

Side effects

With all extended-cycle COCPs, breakthrough bleeding is the most common side effect, although it tends to decrease over time.[14] 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.[15] 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."[16] 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.[14] It was first developed by Barr Pharmaceuticals, in collaboration with Eastern Virginia Medical School, under an agreement.[17] The U.S. Food and Drug Administration (FDA) approved Seasonale in the United States on September 5, 2003.[18] Barr Pharmaceuticals, its manufacturer, claimed at the time of Seasonale's approval that it would cost one dollar per pill.[17] Health Canada approved Seasonale in July 2007, and Paladin Labs began distributing it in Canada on January 4, 2008.[19][20]

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.[21] The FDA approved Lybrel for human consumption on May 22, 2007.[21]

References

  1. ↑ Wright, KP; Johnson, JV (October 2008). "Evaluation of extended and continuous use oral contraceptives". Therapeutics and Clinical Risk Management. 4 (5): 905–11. doi:10.2147/tcrm.s2143. PMC 2621397. PMID 19209272.
  2. ↑ "Health Matters: Understanding Menstrual Suppression". Association of Reproductive Health Professionals. October 2006. Retrieved 2007-11-16.
  3. ↑ Contraceptive technology. Hatcher, Robert A. (Robert Anthony), 1937- (20th rev. ed.). New York, N.Y.: Ardent Media. 2011. p. 257. ISBN 978-1597080026. OCLC 244395421.{{cite book}}: CS1 maint: others (link)
  4. ↑ Organon (September 15, 2005). "NuvaRing is effective and well tolerated in extended use - Most women would like to decrease their number of periods a year". Archived from the original on December 12, 2007. Retrieved 2008-05-04.
    Miller L, Verhoeven CH, Hout J (2005). "Extended regimens of the contraceptive vaginal ring: a randomized trial". Obstet Gynecol. 106 (3): 473–82. doi:10.1097/01.AOG.0000175144.08035.74. PMID 16135576. S2CID 46164922.
    Barreiros FA, Guazzelli CA, de Araujo FF, Barbosa R (2007). "Bleeding patterns of women using extended regimens of the contraceptive vaginal ring". Contraception. 75 (3): 204–8. doi:10.1016/j.contraception.2006.10.009. PMID 17303490.
  5. ↑ Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ (June 2005). "Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial". Obstet Gynecol. 105 (6): 1389–96. doi:10.1097/01.AOG.0000160430.61799.f6. PMID 15932834. S2CID 8831803.
  6. ↑ "Lunelle (Monthly Injection)". Feminist Women's Health Center. January 2006. Archived from the original on 2007-05-29. Retrieved 2007-06-17.
  7. ↑ Rowlands S (October 2007). "Contraception and abortion". J R Soc Med. 100 (10): 465–8. doi:10.1258/jrsm.100.10.465. PMC 1997258. PMID 17911129.
  8. ↑ Gladwell, Malcolm (2000-03-10). "John Rock's Error". The New Yorker. Archived from the original on 2013-12-03. Retrieved 2016-02-17.
  9. ↑ Kripke C (2006). "Cyclic vs. continuous or extended-cycle combined contraceptives". American Family Physician. 73 (5): 804. PMID 16529087. Archived from the original on 2007-09-29. Retrieved 2007-06-17.
  10. 1 2 3 Edelman, Alison; Micks, Elizabeth; Gallo, Maria F.; Jensen, Jeffrey T.; Grimes, David A. (2014-07-29). "Continuous or extended cycle vs. cyclic use of combined hormonal contraceptives for contraception". The Cochrane Database of Systematic Reviews (7): CD004695. doi:10.1002/14651858.CD004695.pub3. ISSN 1469-493X. PMC 6837850. PMID 25072731.
  11. ↑ Coffee AL, Kuehl TJ, Willis S, Sulak PJ (2006). "Oral contraceptives and premenstrual symptoms: comparison of a 21/7 and extended regimen". Am. J. Obstet. Gynecol. 195 (5): 1311–9. doi:10.1016/j.ajog.2006.05.012. PMID 16796986.
  12. ↑ Gerschultz KL, Sucato GS, Hennon TR, Murray PJ, Gold MA (2007). "Extended cycling of combined hormonal contraceptives in adolescents: physician views and prescribing practices". The Journal of Adolescent Health. 40 (2): 151–7. doi:10.1016/j.jadohealth.2006.09.013. PMID 17259055.
  13. ↑ "Menstruation Is Not A Disease". Society for Menstrual Cycle Research. 2007-06-08. Archived from the original on 2007-10-12. Retrieved 2007-11-16.
  14. 1 2 Anderson FD, Gibbons W, Portman D (2006). "Long-term safety of an extended-cycle oral contraceptive (Seasonale): a 2-year multicenter open-label extension trial". Am. J. Obstet. Gynecol. 195 (1): 92–6. doi:10.1016/j.ajog.2005.12.045. PMID 16813747.
  15. ↑ Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD (2006). "Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results". Contraception. 74 (6): 439–45. doi:10.1016/j.contraception.2006.07.005. PMID 17157099.
  16. ↑ "Seasonale (levonorgestrel/ethinyl estradiol) Tablets MACMIS ID #12748: 2004" (PDF). United States Department of Health & Human Services. December 2003. Archived from the original (PDF) on 2006-10-14. Retrieved 2006-10-22.
  17. 1 2 "Seasonale Extended Cycle OC Approved". About.com. February 2003. Retrieved 2006-10-22.
  18. ↑ "FDA Approves Seasonale Oral Contraceptive". United States Food and Drug Administration. September 5, 2003. Archived from the original on 2006-10-07. Retrieved 2006-10-22.
  19. ↑ Magnan, Michelle, 2007-07-06, Health Canada approves Seasonale, Calgary Herald.
  20. ↑ "Paladin Labs Announces SEASONALE Launch". Paladin Labs, Inc. 2008-01-04. Archived from the original on 2013-01-19. Retrieved 2008-02-06.
  21. 1 2 "FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women the Opportunity to Be Period-Free Over Time". PR Newswire Association. 2007-05-22. Archived from the original on May 25, 2007. Retrieved 2007-06-17.

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