Recent Advances in Oral and Transdermal Contraception

Peggy Piascik, PhD

Disclosures

US Pharmacist. 2008;33(9):19-23. 

In This Article

Extended-cycle Oral Contraceptives

Extended-cycle products differ from traditional 21/7 COCs by decreasing or eliminating the hormone-free interval (HFI). A variety of dosing schedules are available ( Table 2 ). Consecutive days of hormone therapy may extend to 84 or 365 days. In add-back regimens, the HFI is shortened to zero, two, or four days instead of the typical seven-day interval. The remaining days supply a lower dose of hormone than that given during the rest of the cycle.

Reasons for switching to an extendedcycle product include the typical menstrual symptoms experienced during the HFI; improving efficacy in women who forget to restart the pill; and patient preference to decrease the frequency of menstrual-like bleeding. For a number of years, prescribers have utilized continuous administration of monophasic pills to simulate an extendedcycle product. However, patients generally incur additional financial expense with this dosing regimen because insurance companies generally pay for only 13 cycles per year.[6]

Women with dysmenorrhea, premenstrual syndrome, premenstrual dysphoric disorder, or endometriosis prior to starting COCs typically experience exacerbations of these symptoms during the HFI. Decreasing or discontinuing the HFI is likely to reduce or eliminate breast tenderness, headache, bloating, cramping, hypermenorrhea, and the psychological symptoms typical of hormone withdrawal. Patients also experience less menstrualblood loss with extended-cycle products, thereby decreasing the risk of iron-deficiency anemia. An additional benefit of extended-cycle products may be improved efficacy. A randomized clinical trial found that continuous COC regimens were more effective at preventing follicular development and breakthrough ovulation during the HFI.[6] These issues are a concern, particularly in patients who have difficulty adhering to the dosing schedule, as low-dose products (20–30 mcg ethinyl estradiol) are the norm.[7]

Extended-cycle products are likely to cause unscheduled bleeding or spotting during active hormone therapy, most commonly during the first few months of therapy. The bleeding and spotting typically improve after several cycles, however. Patients must weigh the convenience of having fewer cycles of scheduled bleeding per year against the possibility of unscheduled bleeding or spotting during the initial stage of therapy.[8]

Studies have compared extendedcycle products with traditional 21/7 products to determine whether patients are more compliant with continuous regimens of a COC. The Coraliance study and many other trials have concluded that extended-cycle products promote compliance and efficacy because patients don't forget to restart the pill after a week-long HFI.[9]

Patients and HCPs have expressed concern that decreasing or eliminating the HFI may be unhealthy and unnatural. Continuous regimens expose women to two additional months of hormone each year and increase lifetime exposure to estrogen and progestin. Concerns raised by HCPs and patients include unforeseen adverse effects and long-term health problems like endometrial hyperplasia, thrombosis, breast cancer, and future fertility.[10] A definitive answer will not be available until long-term studies of extended-cycle products are completed. To date, no studies supporting these concerns have been published.

The Association of Reproductive Health Professionals (ARHP) commissioned a survey to determine women's views about menstrual cycling and the use of hormonal contraceptives. Almost one-half of survey participants said that they would choose to never have a period, and approximately one-quarter said that they would choose to continue to have monthly cycles.[6] Another ARHP study found that women would choose extended-cycle products if they were safe, did not affect future fertility, and did not increase adverse effects; cost was also a factor.[10] In the same study, 44% of HCPs believed that menstrual suppression is a good idea and 52% prescribed oral contraceptives for that reason.[10] Among patients and HCPs (7%) who believed that menstruation is physiologically necessary, reasons cited included the importance of confirming that pregnancy did not occur during the previous cycle and the beliefs that menstruation is a natural state and withdrawal bleeding is necessary to cleanse the system.[10]

Proponents of extended-cycle contraception note that modern women experience about 450 cycles in their lifetime, compared with only 160 cycles for the pre–Industrial Revolution woman.[11] The increased number of cycles for modern women is due to multiple factors, including earlier menarche, later menopause, fewer pregnancies, and less breast-feeding.[11] Economically speaking, eliminating menstrual disorders may improve women's work productivity and decrease health care costs. Data collected from 1984 through 1992 found that menstrual disorders were the most commonly reported gynecologic condition.[12] More than 75% of women studied had consulted a doctor about this condition, and nearly 30% had spent one or more days in bed in the previous year.[12] A 2002 study concluded that menstrual bleeding has a significant economicimpact for working women, with an estimated annual cost of $1,692 per woman in the workplace.[13]

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