Extended cycle combined hormonal contraceptive

Extended cycle combined hormonal contraceptives
Background
Birth control type	Hormonal
First use	?
Pregnancy rates (first year)
Perfect use	?
Typical use	?
Usage
Duration effect	varies
Reversibility	Yes
User reminders	varies
Advantages and disadvantages
STD protection	No
Periods	Eliminates or reduces frequency
Benefits	Reduce menstruation related symptoms, reduce risk of anemia

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.^[1]

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^[2] and the contraceptive patch^[3] have been studied for extended cycle use, and the monthly combined injectable contraceptive may similarly eliminate bleeding.^[4]

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.^[5]

Seasonale was first developed by Barr Pharmaceuticals, in collaboration with Eastern Virginia Medical School, under an agreement.^[6] The U.S. Food and Drug Administration (FDA) approved Seasonale in the United States on September 5, 2003.^[7] Barr Pharmaceuticals, its manufacturer, claimed at the time of Seasonale's approval that it would cost one dollar per pill.^[6] Seasonale is one of Barr Pharmaceuticals' 22 oral contraceptive products.^[8] Health Canada approved Seasonale in July 2007, and Paladin Labs began distributing it in Canada on January 4, 2008.^[9][10]

The FDA approved Lybrel for human consumption on May 22, 2007. Lybrel is currently available at pharmacies by prescription only.^[11]

Usage

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.^[12] 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 endometriosis, dysmenorrhea, and menstruation-associated symptoms.^[13] 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.^[13][14]

More recently, personal preference to avoid menstruation has also become a common reason for use.^[13] Personal preference is the most common reason extended cycle or continuous use COCPs are prescribed to adolescents.^[15] 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.^[16]

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.^[13]

Side effects

With all extended-cycle COCPs, breakthrough bleeding is the most common side effect, although it tends to decrease over time.^[17] 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.^[18] 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."^[19] 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.^[17]

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.^[11]

References

1. ^ "Health Matters: Understanding Menstrual Suppression". Association of Reproductive Health Professionals. October 2006. http://www.arhp.org/healthmatters/UnderstandingMenstrualSuppression.cfm. Retrieved 2007-11-16. 
2. ^ 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". http://www.organon.com/media/press_releases/2005_09_15_nuvaring_is_effective_and_well_tolerated_in_extended_use.asp. 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 (inactive 2009-11-04). PMID 16135576. 
   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. 
3. ^ 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 (inactive 2009-11-04). PMID 15932834. 
4. ^ "Lunelle (Monthly Injection)". Feminist Women's Health Center. January 2006. Archived from the original on 2007-05-29. http://web.archive.org/web/20070529152656/http://www.fwhc.org/birth-control/lunelle.htm. Retrieved 2007-06-17. 
5. ^ Gladwell, Malcolm (2000-03-10). "John Rock's Error". The New Yorker. http://www.gladwell.com/2000/2000_03_10_a_rock.htm. Retrieved 2009-02-04. 
6. ^ ^{a b} "Seasonale Extended Cycle OC Approved". About.com. February 2003. http://headaches.about.com/cs/women/a/seasonale.htm?terms=seasonale. Retrieved 2006-10-22. 
7. ^ "FDA Approves Seasonale Oral Contraceptive". United States Food and Drug Administration. September 5, 2003. Archived from the original on 2006-10-07. http://web.archive.org/web/20061007101134/http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01251.html. Retrieved 2006-10-22. 
8. ^ "Barr Pharmaceuticals, Inc - Key Generic Products - Oral Contraceptives". Barr Pharmaceuticals. Archived from the original on 2006-10-17. http://web.archive.org/web/20061017060500/http://www.barrlabs.com/generic/keyproducts/contraceptives.php. Retrieved 2006-10-22. 
9. ^ Magnan, Michelle, 2007-07-06, Health Canada approves Seasonale, Calgary Herald.
10. ^ "Paladin Labs Announces SEASONALE Launch". Paladin Labs, Inc.. 2008-01-04. http://cnrp.ccnmatthews.com/client/paladin_labs/releaseen.jsp?year=2008&actionFor=807154&releaseSeq=1. Retrieved 2008-02-06. 
11. ^ ^{a b} "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. http://sev.prnewswire.com/health-care-hospitals/20070522/NYTU19322052007-1.html. Retrieved 2007-06-17. 
12. ^ 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. http://web.archive.org/web/20070929104832/http://www.aafp.org/afp/20060301/cochrane.html#c3. Retrieved 2007-06-17. 
13. ^ ^{a b c d} Edelman AB, Gallo MF, Jensen JT, Nichols MD, Schulz KF, Grimes DA (July 2005). "Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception". Cochrane database of systematic reviews (Online) (3): CD004695. doi:10.1002/14651858.CD004695.pub2. PMID 16034942. 
14. ^ 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. 
15. ^ 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 : official publication of the Society for Adolescent Medicine 40 (2): 151–7. doi:10.1016/j.jadohealth.2006.09.013. PMID 17259055. 
16. ^ "Menstruation Is Not A Disease". Society for Menstrual Cycle Research. 2007-06-08. Archived from the original on 2007-10-12. http://web.archive.org/web/20071012033353/http://menstruationresearch.org/position/menstrual-suppression-new-2007/. Retrieved 2007-11-16. 
17. ^ ^{a b} 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. 
18. ^ 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. 
19. ^ "Seasonale (levonorgestrel/ethinyl estradiol) Tablets MACMIS ID #12748: 2004" (PDF). United States Department of Health & Human Services. December 2003. Archived from the original on 2006-10-14. http://web.archive.org/web/20061014104309/http://www.fda.gov/cder/warn/2004/12748.pdf. Retrieved 2006-10-22. 

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?. Lincoln, NE: Backinprint.com. ISBN 978-0595386550. 
• Susan Rako (2003). No More Periods?: The Risks of Menstrual Suppression. Harmony Books. ISBN 1400045037. 

External links

• Lybrel official site
• Seasonale and Seasonique official site
• Pro-extended cycle COCP site by Leslie Miller, M.D.