DR SULAK: We are finally seeing the demise of 21/7 contraceptive regimens. Numerous studies of these regimens over the past decade have documented hormone withdrawal symptoms, inadequate pituitary-ovarian suppression, follicular development, and even ovulation. Regimens which shorten or eliminate the 7-day HFI by adding estrogen and providing greater duration of active pills will improve the side effect profile and efficacy.
Oral contraceptives first gave women control over their fertility; now, regimens that extend the cycle and eliminate the HFI give women the option of having fewer hormone withdrawal symptoms. In addition to the convenience of fewer cycles per year, women may experience further benefit from prolonged suppression of ovulation and menstruation.
While breakthrough bleeding and spotting occur with all OCs, the pattern seen with extended regimens differs. It can be managed with patient counseling and brief pill holidays. Additional strategies to manage breakthrough bleeding that should be evaluated in the future include additional estrogen only, nonsteroidal anti-inflammatory drugs, and changing the estrogen dose of the formulation (ie, increasing the dose from 20 mcg EE to 30-35 mcg EE).
Articles of interest
Anderson FD, Gibbons W, Portman D. Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol. Contraception. 2006;73:229-234.
Prospective trial of 1006 sexually active adult women of childbearing potential who received a 91-day extended regimen OC (30 mcg EE/150 mcg LNG) with continuous low-dose EE (10 mcg) during the hormone free interval. Cycle control and safety of the regimen were comparable to that reported for other OCs.
Anderson FD, Gibbons W, Portman D. Long-term safety of an extended-cycle oral contraceptive (Seasonale): a 2-year multicenter open-label extension trial. Am J Obstet Gynecol. 2006;195:92-96.
Long-term safety study of a 91-day extended cycle OC regimen. Overall rates of study discontinuation and incidence of adverse events were similar to those of an earlier Phase 3 clinical trial. The regimen was well tolerated and the numbers of reported bleeding and/or spotting days diminished during the study.
Foster DG, Parvataneni R, de Bocanegra HT, Lewis C, Bradsberry M, Darney P. Number of oral contraceptive pill packages dispensed, method continuation, and costs. Obstet Gynecol. 2006;108:1107-1114.
Evaluation of the effect of the number of cycles of OC pill packages dispensed on the method continuation, pill wastage, use of services, and health care costs among 82,319 women enrolled in the California Family PACT system. Dispensing a year’s supply of OCs during first visits was associated with a higher method continuation and lower health care costs than dispensing fewer cycles per visit.
Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med. 2002;346:2025-2032.
A population-based, case-control study of 4575 women with breast cancer and 4682 controls to determine the risk of breast cancer among former and current users of OCs. The relative risk of breast cancer was 1.0 (95% CI, 0.8-1.3) for women who were currently using OCs and 0.9 (95% CI, 0.8-1.0) for those who had previously used them. The relative risk did not increase consistently with longer periods of use or with higher doses of estrogen. Use of OCs by women with a family history of breast cancer was not associated with an increased risk of breast cancer nor was the initiation of OC use at a young age.
Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996;54:71-77.
Double-blind, randomized trial to determine the suppressive effect on ovarian activity of OCs administered for 21 or 23 days. Observed differences in 17β-estradiol levels and follicular development between a 21-day and 23-day preparation suggest that shortening the pill-free interval in combined OCs may increase the contraceptive safety margin in women on low-dose formulations.
Sulak PJ, Scow RD, Preece C, Riggs MW, Kuehl TJ. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol. 2000;95:261-266.
Prospective evaluation to measure the timing, frequency, and severity of hormone-related symptoms in OC users. Pelvic pain, headaches, use of pain medication, bloating or swelling, and breast tenderness occurred significantly more frequently during the 7-day hormone free interval among both current users and new start users of OCs.
Sulak PJ, Kuehl TJ, Coffee A, Willis S. Prospective analysis of occurrence and management of breakthrough bleeding during an extended oral contraceptive regimen. Am J Obstet Gynecol. 2006;195:935-941.
Single-center, prospective analysis of self-rated menstrual flow during a 21/7 regimen versus a 168-day extended OC regimen. Subjects with a heavier daily flow rating during the 21/7 day cycle tended to have greater daily flow ratings and earlier breakthrough bleeding during the 168-day extension cycle. The 168-day extended regimen had an acceptable bleeding profile with bleeding during the active pill interval effectively managed with institution of a 3-day hormone free interval.