- CONDITION CENTERS
Dr. Pino is an assistant professor of pharmacy practice at Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, Florida.
Menstruation is a natural biologic process that can have a significant impact on the quality of life for many women. For some women, it is simply a minor inconvenience, but for others, it can be a major health concern.1 Recognized menstrual cycle-related disorders affect approximately 2.5 million women between the ages of 18 and 50 years in the United States alone.2 These disorders not only contribute significantly to health care costs but also have an economic impact due to decreased productivity and time lost from work.1 Oral contraceptives (OCs) are the most common method of reversible contraception and are also used extensively to manage menstrual disorders, such as endometriosis, dysmenorrhea, menorrhagia, and premenstrual symptomatology.3
In a normal menstrual cycle, estrogen secreted from a stimulated follicle promotes endometrial growth to allow for implantation of a fertilized egg. A surge in luteinizing hormone eventually causes ovulation, and the follicle leaves behind the corpus luteum. Progesterone is secreted from the corpus luteum as the body prepares for possible fertilization. Without successful fertilization and implantation, estrogen and progesterone levels will decline as the corpus luteum regresses, leading to menstruation.1
The primary action of combination OCs is to suppress the hypothalamic- pituitary system, decreasing the secretion of gonadotropin-releasing hormone, resulting in the inhibition of ovulation. Thus, the bleeding experienced by women taking OCs during their hormone-free interval tends to be lighter, shorter, and more regular than natural menstruation.4
Currently, most contraceptive regimens employ a 28-day schedule, with 21 to 24 days of active therapy and 4 to 7 hormone-free days, in accordance with a historic desire to mimic the natural cycle by causing regular withdrawal bleeding. This periodic bleeding, which is perceived by women as menstruation, was very important to the initial acceptance of the pill for psychological, not medical, purposes. In actuality, the bleeding experienced during this hormone-free interval is not considered to have a biologic purpose and is not a physiologic requirement.5
These hormone-free intervals have proved to be problematic for many women who suffer from conditions that are aggravated during menstruation, such as dysmenorrhea and menorrhagia. In addition, hormone withdrawal symptoms, such as mood swings, pelvic pain, and headaches, are commonly experienced. For these reasons, continuous OC therapy-without the usual hormone-free interval each cycle-has been used for decades to suppress menses safely and effectively.1
Extended-Cycle OC Options
OCs taken continuously for more than 28 days compare favorably to traditional cyclic OCs with regard to bleeding episodes, discontinuation rates, and reported satisfaction.6 These regimens reduce the days of withdrawal bleeding, with the intent of improving contraceptive effectiveness, patient adherence, patient tolerance, and reducing adverse effects.7
In a multicenter, randomized study of an extended-cycle OC, the adverse event profiles of the extended-cycle regimen and conventional regimen were comparable and similar to those of other OCs. In addition, hormone withdrawal symptoms that occur on 21/7 OC regimens respond relatively quickly to an extended regimen, with maximal improvement usually seen within the first few weeks with persistent long-term improvement.8
The extended-cycle regimen represents a change in the paradigm of OC therapy, allowing women the option of decreasing the number of withdrawal bleeding intervals they experience in 1 year.8 Various contraceptives that decrease the number of hormone-free days each cycle or that increase the time between hormone-free intervals are now available. For example, Seasonale (0.15 mg levonorgestrel/0.03 mg ethinyl estradiol) is an extended-cycle OC product in which an active pill is taken every day for 12 weeks, followed by 7 days of placebo pills.4 Seasonique is also an extended-cycle OC, but differs from Seasonale in that it contains 7 days of low-dose estrogen pills (0.01 mg ethinyl estradiol) instead of placebo pills to reduce breakthrough bleeding and estrogen withdrawal symptoms.9
Lybrel (90 mcg levonorgestrel/20 mcg ethinyl estradiol), the newest OC in this category, is the first and only low-dose combination contraceptive pill that is taken 365 days a year without a hormone-free interval. The amenorrhea that is caused by this daily low dose of hormones allows for increased efficacy in the reduction of pregnancy and a reduction or elimination of symptoms associated with menstruation.10
Good pharmacist-patient communication is essential to the successful use of extended-cycle OCs.11 To minimize nausea, patients are often instructed to take OCs with their evening meal or at bedtime; however, it is important that the patient take the tablet at the same time every day to maximize contraceptive efficacy. If 2 or more active tablets are missed, the patient should be instructed to use another method of nonhormonal backup contraception until she has taken an active tablet daily for 7 consecutive days. Patients also should be reminded that the risk of pregnancy increases with each active tablet that is missed.10
Because regular monthly bleeding does not occur while taking extended-cycle OCs, patients may have difficulty recognizing if they are pregnant. If a patient suspects that she may be pregnant or experiences symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, she should be counseled to take a pregnancy test or contact her health care provider. In addition, women should be reminded that they should stop taking their OCs if they become pregnant.10
Patients also should be advised that breakthrough bleeding and spotting is likely when taking extended-cycle OCs; however, this should decrease over time. If breakthrough bleeding or spotting is problematic, the institution of a 3-day hormone-free interval is usually effective management in the majority of women. Persistent bleeding or spotting that does not resolve with the institution of an abbreviated hormone-free interval should warrant further evaluation, such as a transvaginal ultrasound to rule out intrauterine or ovarian pathologies as possible causes.3
Due to the increased risk of venous thromboembolism in women taking OCs, patients should be counseled to contact their health care provider if they experience severe abdominal pain, chest pain, leg pain, headaches, or visual disturbances, as these may be signs of a serious medical condition. Patients also should be encouraged to avoid tobacco products, as smoking can increase the risk of adverse events.10
Patients taking OCs should be educated on the fact that certain medications, such as antibiotics, may interfere with the effectiveness of their birth control. Therefore, patients should consult their doctor or pharmacist to ensure that a drug interaction is not present before starting new medications or herbal remedies. Patients also need to be reminded that the use of OCs does not prevent the transmission of sexually transmitted diseases, and the use of a condom when engaging in sexual activity should be encouraged. In addition, patients should be instructed to store their medication at room temperature and out of the reach of children.10
With proper pharmacist-patient counseling, extended-cycle OCs are a safe and effective way to manage menstrual disorders. These products provide women with the option of decreasing the number of bleeding episodes they experience per year and can significantly improve the quality of life in these patients.
1. Archer DF. Menstrual cycle related symptoms: a review of the rationale for continuous use of oral contraceptives. Contraception. 2006;74(5):359-366.
2. Kjerulff KH, Erickson BA, Langenberg PW. Chronic gynecological conditions reported by US women: findings from the National Health Interview Survey, 1984-1992. Am J Public Health. 1996;86(2):195-199.
3. Coffee AL, Sulak PJ, Kuehl TJ. Long-term assessment of symptomatology and satisfaction of an extended oral contraceptive regimen. Contraception. 2007;75(6):444-449.
4. Seasonale [prescribing information]. Seasonale Web site. www.seasonale.com/pdfs/seasonale_prescribing_info.pdf. Accessed February 25. 2008.
5. Anderson FD, Hait H. The Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68(2):89-96.
6. Edelman AB, Gallo MF, Jense JT, Nicholas MD, Schulz KF, Grimes DA. Continuous or extended cycle versus cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2005; Jul 20(3):CD004695.
7. Masimasi N, Sivanandy MS, Thacker HL. Update on hormonal contraception. Cleve Clin J Med. 2007;74(3):186-198.
8. Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68(2):89-96.
9. Seasonique [prescribing information]. Seasonique Web site. www.seasonique.com/Files/PrescribingInfo.pdf. Accessed February 25. 2008.
10. Lybrel [prescribing information]. Lybrel Web site. www.lybrel.com/prescribing_information. Accessed February 25. 2008.
11. Nelson AL. Communicating with patients about extended-cycle and continuous use of oral contraceptives. J Womens Health. 2007;16(4):463-470.