Extended-cycle OCs: What you should know
Before the introduction of oral contraceptives (OCs) in the 1960s, many women referred to their monthly periods as “my friend.” If a woman's “friend” arrived on time, it meant she had not gotten pregnant that month. And in the days when giving birth could be life-threatening, that was often good news indeed, despite the mess and hassle menstruation entailed.
An estimated 16 million women in the United States now use OCs, and for the most part they have served women well. These days, though, women often want more. Many women would just as soon avoid monthly bleeding altogether or would at least prefer that their periods be considerably lighter and shorter. The new extended-cycle OCs can often grant women their wish.
Of course, primary-care clinicians and their patients taking OCs have long known that women can avoid monthly bleeding by skipping the placebo pills in their pill packs and going directly to the active medication in the next pack. This can be done for several months at a time or continuously, with just an occasional five- to seven-day placebo or no-pill break. For years, clinicians have prescribed such extended-cycle or continued-use regimens for women with endometriosis, clotting disorders, anemia, and other medical conditions made worse by menstruation.
The good news is that in the past few years, a number of studies have documented the safety of using OCs this way. In 2003, the FDA approved a levonorgestrel/ethinyl estradiol (EE) pill under the brand name “Seasonale,” which is packaged for a 91-day extended cycle.
It contains 84 active pills and seven placebo pills. An updated version of Seasonale, also made up of levonorgestrel/EE and called Seasonique, is available. Instead of seven placebo pills, Seasonique includes seven spacer pills containing tiny doses of estrogen (EE 0.01 mg), which is added to help reduce bloating and the amount of withdrawal bleeding. (The makers of the desogestrel/EE [Mircette] pill have also been adding 0.01 mg EE to five of its seven placebos for several years, with good results.)
In June 2006, the FDA postponed approval of yet another levonorgestrel/EE combination (Lybrel), a low-dose OC designed to end periods altogether. Quality control concerns about the offshore manufacturing plant were partially to blame. However, based on studies submitted to the FDA, approval is anticipated and may occur in the near future.
While extended-cycle or continuous-use regimens work well for about 75% of women, the remaining 25% experience persistent, unscheduled breakthrough bleeding and spotting. Spotting tends to diminish over time as long as no pills are missed, however, and some women's bodies ultimately adjust to a shorter extended-use regimen of six or eight rather than 12 weeks, which still results in fewer periods a year. However, a sizable minority of women do end up returning to a more predictable 28-day cycle, with 21 active pills followed by seven placebo pills.
Lengthening a woman's cycle
When one of my patients wants to try an extended-cycle regimen of whatever length, I instruct her to expand her pill cycle gradually, by first skipping just one week of placebo pills. If breakthrough bleeding occurs, I have her take the next set of placebo pills, followed by another attempt at skipping them. Once a woman is able to get through two sets of 21 active pills in a row with no breakthrough bleeding, I tell her to extend the number of cycles without placebo pills to three or more.
An alternate method is to have a woman take active pills continuously (for at least 21 days) until breakthrough bleeding occurs, and then have her stop and take either placebo or no pills for five to seven days. After that, have the patient begin taking active pills again until a second episode of breakthrough bleeding occurs, followed by another break for five to seven days, and so on. Over time, the number of days before breakthrough bleeding occurs will increase, although not much beyond 84 days for most women.
Kinder, gentler periods
While some women are quite happy having few or no periods, others would like to continue to be regularly reassured that they are not pregnant. For such patients, two additional new OC products are now available: drospirenone/EE (Yaz) and norethindrone/EE (Loestrin 24 Fe). Both use 24 rather than 21 days of active pills, followed by four days of placebos for Yaz and four days of 75-mg ferrous fumarate pills for Loestrin 24 Fe.
Yaz is a 0.02-mg EE version of the anti-androgenic and anti-mineralocorticoid drospirenone/EE OC (Yasmin), which is marketed as acne therapy. Both Yasmin and Yaz contain 3 mg of drospirenone, but Yasmin has 0.03 mg of EE while Yaz has only 0.02 mg. In Europe, the 0.02-mg EE version is marketed (under the name “Yasminelle”) as simply a lower-dose acne pill with 21 active tablets. In the United States, the 0.02-mg dosage is repackaged presumably as a marketing answer to Loestrin 24 Fe, under the name “Yaz.” Based on a study of 450 women with premenstrual dysphoric disorder (PMDD), a more severe version of PMS, Yaz is also approved for treating the physical and emotional symptoms of PMDD, but only in women who choose the pill as their form of contraception. (Selective serotonin reuptake inhibitors have also been shown to be an effective treatment of severe PMS and PMDD, and several are approved for the PMDD indication.)
Loestrin 24 Fe is a variant of Loestrin Fe 1/20. The products are identical, except that Loestrin Fe 1/20 has only 21 active pills and seven ferrous fumarate pills. While the amount of iron contained in either formulation is too small to make a therapeutic difference, it is just enough to make some women constipated and give others diarrhea. A multicenter study of nearly 1,000 women comparing Loestrin 24 Fe with Loestrin 1/20 found that women taking Loestrin 24 Fe had shorter periods — 2.7 days on average at the end of six cycles compared with 3.9 days with Loestrin 1/20.
A 0.015-mg EE, 24-day-cycle product with only four placebo pills, resulting in very light withdrawal bleeding, has been used successfully in Europe for several years. To date, the FDA has not approved any 0.015-mg EE pills.
How low can you go?
The real progress in the formulation of OCs has been the gradual reduction of estrogen and the concomitant decline in such cardiovascular risks as thromboembolism, which were a disturbing side effect of older, now-abandoned OC formulations. Today, practically all OCs, including the most recently developed ones, contain at most 0.03 mg EE. With the 0.015-mg EE products, we seem to have reached the lowest possible estrogen dose that still achieves the two main goals of OCs, namely contraception and cycle control.
For most women, improved appearance of the skin and relief from menstruation-associated symptoms is a class effect of all OCs currently on the market. For some, the more anti-androgenic and antimineralocorticoid progestin drospirenone offers additional benefits for the control of acne and severe menstrual disorders.
There is no indication that the newer products differ from the other £0.03-mg EE products either in their risk and side- effect profiles or in their established health benefits, which include reduced risk of ovarian and endometrial cancer, pelvic inflammatory disease, endometriosis, and ovarian cysts.