Are there specific clinical advantages to extended regimen OCs?
DR LONDON: The real advantage to the extended regimens is that they do not have the disadvantages known to exist with the 21/7 regimens.
DR KAUNITZ: There are 4 advantages to extended regimens:
• improvement in contraceptive success
• therapeutic use for hormone withdrawal symptoms
• treatment of gynecologic problems such as dysmenorrhea, endometriosis, and anemia
• accommodation of lifestyle preference
Once women understand that extending combined hormone contraceptives is safe, most will prefer fewer cycles.
DR SULAK: While we need to acknowledge that the decision to introduce the first OCs in a 21/7 regimen was a wise choice nearly 50 years ago, research has shown us that the low doses of EE and the 7-day HFI creates problems—incomplete pituitary-ovarian suppression, endogenous estradiol formation, follicular development, ovarian cyst formation, risk of escape ovulation, and hormone withdrawal symptoms. It doesn’t matter whether a pill, patch, or ring is used—a 7-day HFI is too long with today’s low-dose combined hormonal contraceptives.
Spona was the first to report greater suppression of ovarian activity with a shortened HFI.7 By increasing the number of active pills from 21 to 23 per cycle and decreasing the HFI from 7 to 5 days, there was lower residual ovarian activity and endogenous 17β-estradiol. The study also showed that 17β-estradiol levels began to rise during the HFI but the rise was earlier and greater in women assigned to the 21-day regimen.
DR KAUNITZ: Another fundamental issue focuses on the reason our patients use OCs—effective, convenient, and reversible contraception. Unfortunately, the current 21/7 paradigm may not be optimal. The “typical” failure rate with OCs—which is what applies to our patients—is 8%.8 I don’t think that is acceptable.
The HFI and the first few days of a new pill pack are the time at which women are at greatest risk for contraceptive failure and unintended pregnancy. By extending the overall duration of active pills and decreasing the duration of the HFI, we are setting our patients up for better contraceptive success.
DR SULAK: There is also the issue of symptoms during the HFI. We all recognize that menstrual symptoms—breast tenderness, headache, bloating, and cramping—increase during the HFI.9 Although our data reported significant hormone withdrawal symptoms in women taking OCs, women experience these symptoms with all forms of combined estrogen-progestin hormonal contraceptives regardless of route of administration.
Importantly, the study showed that the symptoms occurred consistently not only in the new start patients, but also in the established users—the women who had been on the pill for more than a year. There is a reason why so many women stop their OCs in less than a year—it’s not because they are feeling wonderful. They may stop because they feel terrible during the HFI.
DR NELSON: The symptoms are real and it is astonishing how many women experience them. Women have become so accustomed to feeling lousy once a month, whether it’s due to menstrual symptoms or hormone withdrawal, that they will not mention it.
Another advantage to extended use of combination estrogen-progestin contraception is the prolonged suppression of ovulation and menstruation, like that produced by the progestin-only regimens, without the negative effects on bone. Given the multitude of problems caused by recurrent ovulation and menstruation, it may be healthier for some women not to have periods every month.
DR KAUNITZ: There are also therapeutic uses for extended regimen OCs that we should not overlook. Decreased dysmenorrhea and menorrhagia are both included in the prescribing information for all OCs. Women suffering from these disorders will likely have additive benefit from extended regimens. In the same vein, the value of extended regimens in managing endometriosis has been known for years.10
DR SULAK: A very recent paper showed that extending the regimen can improve premenstrual symptoms.11 When symptomatology was compared with that recorded during a 21/7 cycle, there was a significant improvement that was especially apparent in the women who had the greatest variability in their cycles.
Another important finding was that the greatest improvement was detected in the sixth month. That is a key counseling point—you need to stick with the regimen to see the benefits.
What practical advantages does an extended regimen offer to the patient?
DR LONDON: Convenience, convenience, convenience.
MS MOORE: The worst pill to miss in any cycle is the one that is still at the pharmacy. Once your patient has already had 7 hormone-free days, her risk of pregnancy increases with each day of delay in starting a new pack of pills.
DR LONDON: With an extended regimen, that risk occurs fewer times per year. Just as the change from 50-mcg pills to low-dose pills was an improvement, the extension of the regimen beyond 28 days is a real improvement in OC therapy.