JOURNAL OF WOMENS HEALTH Volume 16, Number 4, 2007 Mary Ann Liebert, Inc. DOI: 10.1089/jwh.2006.

0206

Clinical Corner Communicating with Patients about Extended-Cycle and Continuous Use of Oral Contraceptives
ANITA L. NELSON, M.D.

ABSTRACT Oral contraceptives (OCs) have been the gold standard for contraception in the United States since their introduction in 1960. They are used for both their contraceptive and noncontraceptive benefits. Although the traditional dosing regimen, 21 active pills and 7 placebo pills, (21/7), reduces many symptoms women suffer with spontaneous cycles, hormone withdrawal symptoms often occur during the 7-day hormone-free interval. New contraceptives are available that decrease the number of hormone-free days each cycle or that increase the time between hormone-free intervals. These changes in packaging are expected to decrease the periodic hormone fluctuations experienced by OC users. Because routine use of extended-cycle/continuous OCs is relatively new and differs from what women have been told for years about the importance of monthly bleeding, women have many questions about and even significant reluctance to using these methods. Numerous studies have shown that extended-cycle and continuous OC use are safe and effective. Total bleeding episodes are reduced, as are problems with bloating and dysmenorrhea. Women usually experience more unscheduled spotting and bleeding in the initial cycles, but those problems decrease with longer use. Amenorrhea may be beneficial and suit the lifestyles of many women. Counseling women about all their contraceptive options and the variety of ways that OCs can be taken may increase womens commitment to correct use and increase efficacy. Good clinician-patient communication, which includes creating an open dialogue with the patient to discuss her individual risks and benefits, should lead to more successful contraceptive utilization.

CLINICAL RATIONALE FOR EXTENDEDCYCLE AND CONTINUOUS USE OF ORAL CONTRACEPTIVES

HE MENSTRUAL CYCLE IS A

tightly orchestrated sequence of stimulating and inhibiting en-

docrinological events, the purpose of which is to cause the release of a single mature oocyte and to promote implantation should fertilization take place. Reproductive failure in a cycle (the lack of an established pregnancy) is followed by a coordinated sloughing of the endometrial lining to

Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, Torrance, California. Dr. Nelson has received research grants from Berlex, Organon, Pfizer, and Wyeth and serves on the advisory board of Barr, Bayer, Organon, and Wyeth and on the speakers bureaus of Barr, Bayer, Esprit, Merck, Organon, Ortho McNeil, Pfizer, Ther-Rx, and Wyeth.

463

464

NELSON

prepare for the possibility of pregnancy in the subsequent cycle. The situation with women using oral contraceptives (OCs) is significantly different: OC users are attempting to prevent pregnancy, and OCs are designed to suppress ovulation and to keep the endometrium thin. There is no biological reason to mimic the menstrual cycle with periodic withdrawal bleeding in OC use. Understanding this pivotal distinction between normal, healthy menstrual cycling and the programmed artificial OC withdrawal bleed is key to helping women understand and benefit from extended-cycle and continuous OC use. This paper reviews the clinical experience with extended-cycle/continuous OC use and reviews the information that would be valuable for women to understand when they start to use OCs for extended cycles or continuously. OCs have been the gold standard for contraception in the United States for more than four decades. Since their introduction, it has become clear that OCs provide extensive noncontraceptive benefits, many of which target menstrual problems, including dysmenorrhea,1,2 menorrhagia,35 and symptoms of premenstrual syndrome611 and premenstrual dysphoric disorder.12 Other conditions that may be exacerbated by menses and, therefore, may also be better controlled by innovative, extended-cycle OC use include catamenial seizures, menstrual migraine, and mood lability.1320 Women with anovulatory cycling (polycystic ovarian syndrome [PCOS]) and those with rapidly fluctuating hormone levels (perimenopause) also benefit from the hormone stability and balance provided by OCs.21 Other general health benefits OC users enjoy include a reduction in the risk of benign breast conditions, ectopic pregnancy, ovarian and endometrial cancer, and iron-deficiency anemia from excessive menstrual blood loss.22,23 The first combination OCs were designed with 21 active pills and 7 placebo pills (21/7) to duplicate the normal menstrual cycle, for reasons that were very relevant at the time.24,25 The placebo pills were deliberately given to induce cyclic, predictable withdrawal bleeding to reassure women using the high-dose formulations that they were not pregnant and that their reproductive systems were still functioning. After 47 years of OC use, however, these reasons are no longer germane. Today, it is clear that the 21/7 dosing regimen offers no documented health benefits. Even though the withdrawal bleeding

symptoms of cyclic OC users are reduced compared with the menstrual problems experienced by spontaneously cycling women, hormone withdrawal symptoms still occur during the 7-day hormone-free interval.26 It is interesting that the 7-day hormone-free interval remained virtually unchanged for decades despite the fact that dramatic changes were made not only in the estrogens and progestins used in the pills but also in the doses of those hormones.2729 Because of these fresh insights, however, the appropriateness of the 7-day hormone-free interval has been the focus of intense investigation and new innovation.30 Two Food and Drug Administration (FDA)-approved products are now available that shorten the pillfree interval to 4 days and maintain cyclic withdrawal bleeding. The focus of this paper, however, is on extended-cycle OC use, which eliminates withdrawal bleeding for many months.

CLINICAL EXPERIENCE WITH EXTENDED-CYCLE AND CONTINUOUS-USE OCs

Patients are often surprised to learn that clinicians have been manipulating the pill-free intervals in the pill packets for women since the 1960s. Women with endometriosis who were treated with continuous OCs had significant reduction in their symptoms,31 as were women who had menstrual migraines and other menstrual symptoms and were given extended cycle OCs. Clinicians have advised women for years about how to take their pills off-label to avoid bleeding during important events, such as honeymoons, business meetings, and athletic competitions. For women not using OCs, other progestin-only methods may also be helpful to delay menses for a short term. New FDA-approved OC formulations now routinely offer women the opportunity to better control their bleeding and to further reduce periodic hormonal fluctuations either by decreasing the number of hormone-free days or by extending the time between hormone-free intervals. Providers may prescribe extra packs of conventional monophasic pill formulations to use in extended cycles, but cost may be an issue for the patient. Reducing the frequency of menstruation through extended cycles or continuous use of OCs offers the same health benefits as conventional 21/7 dosing regimens but also provides more complete relief from hormone withdrawal symptoms. Specifi-

EXTENDED-CYCLE AND CONTINUOUS USE OF OC

465

cally, studies have shown that extended cycles/ continuous use of OCs reduced the frequency and severity of headache, genital irritation, tiredness, breast tenderness, bloating, and menstrual pain.3134 Women whose underlying medical problems are exacerbated by menstruation (catamenial seizures or asthma attacks) may benefit from reducing the frequency of or eliminating menstruation.24 Additionally, there is evidence to suggest that women using extended-cycle or continuous OCs have a lower risk for follicular development, particularly if they inadvertently expand that interval by missing pills at its beginning or end.3537 Follicular development occurs during the hormone-free interval37; extended-cycle OC use more effectively prevents dominant follicle development and breakthrough ovulation.38

BLEEDING PATTERNS WITH EXTENDED-CYCLE AND CONTINUOUS OC USE

Once patients understand the rationale behind eliminating the periodic scheduled withdrawal bleeding, they can appreciate that changing the way they take their pills may improve the effectiveness of the pill and their own quality of life. They also need to understand the transitional bleeding changes they are likely to experience when they first start to use pills in this fashion. Because there are no evidence-based treatments to deal with this unscheduled bleeding or spotting or both, it is particularly important that women be adequately informed about this possibility. Numerous studies have provided reasonably consistent information for clinicians to use when counseling patients about this potential side effect. The first point that needs to be made is that scheduled withdrawal bleeding is dramatically reduced from the very beginning. Women often worry that by delaying their bleeding, they will have heavier and longer flows when they do bleed. Women in the comparative clinical trials actually had shortened flows during an extendedcycle bleeding episode than any one of the episodes of bleeding they had with cyclic use of the same OCs.31 However, most studies showed that women have more days of unscheduled spotting and bleeding in the first few cycles, but the frequency of those events decreases dramatically in later cycles. It is important to emphasize that even in the early cycles, total blood loss (sched-

uled unscheduled episodes together) was less with extended-cycle/continuous OC use than with cyclic OC use. A 1-year open-label trial, in which 682 subjects were randomized to receive either 91-day cycles (84/7) or 28-day cycles (21/7) of an OC containing 150 mcg levonorgestrel/30 mcg ethinyl estradiol (EE), found that the incidence of unscheduled bleeding decreased over the course of the trial. The unscheduled bleeding and spotting were comparable for both groups in the last 3 months of the study, although a greater percentage of women in the extended-cycle arm (7.7%) discontinued because of bleeding side effects than did the cyclic OC users (1.8%).39 Another trial, which studied the same formulations but replaced the 7 placebo pills with 7 pills containing 10 mcg EE each, also found that unscheduled bleeding decreased significantly after the first cycle. Median days of unscheduled bleeding and spotting dropped from 11 to 4 between the first and fourth 90-day cycle. Approximately 50.3% of women in the extended-cycle arm discontinued pill use, but only 16.3% discontinued for all adverse events, including bleeding problems.40 Not all studies have found increases in unscheduled bleeding and spotting with extended-cycle OC use. In one study of 90 women comparing a 21/7 regimen to a 42/7 regimen of 300 mcg norgestrel/30 mcg EE, extended cycle users had fewer days of scheduled bleeding and no increase in days of unscheduled spotting or bleeding.31 Another small study of 32 women found that those who used 100 mcg levonorgestrel/20 mcg EE pills for 168 days had fewer days of bleeding and an increased incidence of amenorrhea compared with women who used that formulation in a 21/7 regimen.34 Continuous use of OCs for 12 consecutive 28day cycles without a hormone-free interval was evaluated in a study of 79 women who were randomized to receive 100 mcg levonorgestrel/20 mcg EE pills in a 21/7 regimen or daily with no placebo pills.41 Amenorrhea was experienced by 16% of the continuous OC users during the first 3 months of the study, but by the last 3 months of the study, 72% were amenorrheic. Unscheduled bleeding increased during the early months of continuous OC use but decreased later. By 9 months, the continuous OC users had less unscheduled bleeding than the cyclic 21/7 regimen OC users. Endometrial aspiration during cycle 9 revealed that 88% of continuous OC users had endometrial atrophy or inactivity, whereas 60% of

466

NELSON

the cyclic OC users had endometrial proliferation. Importantly, none of the OC users in any of these studies had endometrial hyperplasia, which is the concern for women with spontaneous oligomenorrhea from anovulatory cycling. A new continuous OC formulation with 90 mcg levonorgestrel/20 mcg EE was evaluated recently with 28 active pills in a pack.42 By the third pill pack, the median number of days of bleeding (episodes that required sanitary protection) was reduced to 0. After pill pack 4, the median numbers of days of unscheduled bleeding or spotting were lower with continuous use of the pill than was seen in cyclic (21/7) users of the same formulations. By pill pack 7, 44.8% of women had achieved complete amenorrhea, and 70.8% had no bleeding that required sanitary protection. Overall, 18.5% of subjects discontinued or were discontinued by the investigator for reasons related to uterine bleeding.42

METABOLIC IMPACTS OF EXTENDEDCYCLE AND CONTINUOUS USE OF OCs

There have been concerns that higher estrogen exposure during extended cycles may increase the incidence of adverse events. However, studies evaluating extended-cycle or continuous OC regimens have demonstrated that these regimens offer safety and tolerability profiles similar to those of monthly cyclic OCs.31,33 A study in which 45 women received a 24-week extended OC regimen containing 75 mcg gestodene/30 mcg EE found that metabolic changes, including changes in blood glucose levTABLE 1. Contraceptive efficacy

els, hemoglobin, lipid profile, and blood pressure, were similar to those observed in studies evaluating 21/7-day regimens.43 Other formulations with other doses of estrogen and different progestins may have other metabolic impacts; each must be individually evaluated.44 Thrombosis is a relatively rare event with OC use, so that even in extensive clinical trial experience with continuous-use OCs, it would be difficult to accurately estimate the risk. However, the risk of thrombosis exists with all OCs and increases when the dose of EE increases from 35 mcg to 50 mcg.45,46 Because use of extended-cycle or continuous OCs does not increase the daily dose of EE and hormones do not accumulate over time, the risk of thrombosis should not increase with extended-cycle OCs. In a recent experience with the 91-day active pill and 7 pills with 10 mcg EE, there was only one thrombotic event, which resulted from traumatic blood drawing in a woman with factor V Leiden mutation. Similarly, because the 35 mcg EE formulations of OCs given to reproductive-aged women have not been shown to increase the risk of breast cancer in current or past users aged 3564, it is not expected that extended-cycle use of 20 or 30 mcg EE pills will show any increase in that risk.47

PATIENT ACCEPTANCE OF EXTENDEDCYCLE AND CONTINUOUS-USE OCs

With appropriate counseling, the use of extended-cycle or continuous-use OCs appears to be widely accepted by women, as shown in studTO

ORAL CONTRACEPTIVE COUNSELING: KEY POINTS

DISCUSS

Safety Side effects Fertility Noncontraceptive benefits Other

All OCs are highly efficacious when taken correctly Missed doses may lead to decreased efficacy of the OC, especially with 21/7-day regimens Precautionary methods should be discussed in the event of a missed dose OCs are clearly safer than pregnancy Risk of venous thrombosis should be discussed, and signs and symptoms should be clearly described, as should other rare health risks Minor side effects may occur upon initial use, including nausea, breast tenderness, and unscheduled bleeding These side effects usually subside within the first few months of initiation Fertility returns rapidly upon discontinuation of OC use Patients should be told to start using another method of contraception as soon as they stop using OCs; they should not wait until their next period Bleeding is decreased with all OCs OCs provide greater cycle predictability if taken cyclicly All OCs are associated with a decreased risk of benign breast disease, pelvic inflammatory disease, and ovarian and endometrial cancers OCs do not protect against sexually transmitted infections

EXTENDED-CYCLE AND CONTINUOUS USE OF OC

467
TABLE 3. ELEMENTS OF INFORMED DECISION MAKING REGARDING OCS51

ies conducted by Sulak et al.48,49 A retrospective analysis was conducted in 220 subjects to evaluate the acceptance, continuation, and variability of extending the active interval of OCs.32 Subjects were to take at least 21 consecutive days of active pills, with no maximum number of consecutive active pill days. Subjects were also advised to stop pills for 34 days if they experienced bothersome unscheduled bleeding or spotting. Of the 181 patients with follow-up data, 67% were still extending at the last follow-up visit. Based on Kaplan-Meier product limit survival analysis, 60% of women continued to use extended patterns of OCs for more than 2 years. Women were allowed to decide when and for how long to have a hormone-free interval; 80% chose a 04-day interval. A similarly designed study found that of the 267 patients (318 initially enrolled) with follow-up data, 21.3% discontinued use of OCs, 14.2% returned to a 21/7-day regimen, and 64.4% were still extending at the last follow-up visit. Using survival analysis methods, approximately 46% of women continued to use an extended regimen at 5 years.48

Discussion of the patients role in decision making Discussion of the clinical issue or nature of the decision Discussion of alternatives Discussion of the potential benefits and risks of the alternatives Assessment of the patients understanding Exploration of patient preference

COMMUNICATING WITH WOMEN ABOUT CONTINUOUS USE OF OCs: WHAT PATIENTS NEED TO KNOW
Patients who are starting or are already taking OCs may have various degrees of understanding about the mechanism of action, noncontraceptive benefits, side effects, and risks associated with OC use. Thus, it is important to provide women with information about these issues. Even if they are long-time OC users, they should be asked about any questions or concerns they may have about their birth control method at regular visits. Many of these points are summarized in Table 1.

TABLE 2. ADDITIONAL COUNSELING POINTS WITH EXTENDED-CYCLE AND CONTINUOUS OC USE Monthly bleeding is not necessary or even healthy when a women is using OCs Use of extended-cycle or continuous OCs may initially be associated with higher rates of unscheduled bleeding compared with 21/7-day conventional dosing regimens Extended-cycle or continuous use of OCs reduces or eliminates withdrawal bleeding, which may better suit the medical or lifestyle needs of some women

The patient should be asked about her expectations for a birth control method and what additional features would make a specific method more appealing (e.g., discretion, noncontraceptive benefits, contraceptive efficacy). Because there are numerous OCs available, a discussion about all available formulations is not feasible; however, several key points should be discussed. First, all OCs have similar contraceptive efficacy, and upon discontinuation, fertility returns rapidly. Second, all OCs provide noncontraceptive benefits to many women, such as decreased menstrual bleeding and greater cycle regularity. The degree of benefit for specific menstruationrelated symptoms varies with each OC and may depend on the dose, formulation, and regimen of the OC, as well as differences between individual women. Finally, there are specific rare but serious risks associated with all OCs, such as thromboembolism; women should be counseled to recognize any of their warning signs. When discussing extended-cycle or continuous-use OCs specifically, several additional points should be discussed (Table 2). First, it should be emphasized that there are no health advantages to using conventional 21/7 regimens over the extended-cycle or continuous use of OCs. It may be beneficial to discuss the historical setting in which the initial formulations were designed (i.e., to reassure women that they were not pregnant) in order to give women a better understanding of and comfort level with extended-cycle or continuous-use OCs. Furthermore, because these new regimens reduce or eliminate menstruation, they often better suit the lifestyle and meet the medical needs of some women. It is also important to discuss the bleeding patterns associated with extended-cycle and continuous-use OCs. Although these regimens are effective at reducing or eliminating scheduled withdrawal bleeding, they are generally associated with more frequent unscheduled bleed-

468

NELSON

ing or spotting initially compared with 21/7 dosing regimens.40,41 Therefore, women taking these regimens should be counseled about the potential for an initial increase in unscheduled bleeding or spotting, along with the benefit of fewer or no periods in the longer term. Results from a recent study demonstrated that introducing a brief hormone-free interval (3 days) after the first 3 weeks of OC use may effectively manage unscheduled bleeding or spotting with extended-cycle or continuous-use OCs, although this may reduce some of the other benefits of extended-cycle use.50 Other interventions that are often recommended for the management of unscheduled bleeding with cyclic formulations may be important with extended-cycle use (e.g., take each pill on time). Other recommendations that have not been tested with extended-cycle OC use (e.g., NSAIDs or changing the estrogen/progestin balance) have been helpful in managing unscheduled bleeding and spotting with other hormonal contraceptives.

CONCLUSIONS
Many women experience menstrual cycle-related symptoms and conditions that may be reduced or alleviated with extended-cycle or continuous OC use. Products and protocols that reduce the frequency of withdrawal bleeding provide women with important options. Considerable evidence supports the conclusion that these extended-cycle/continuous-use regimens are at least as effective and safe as the 21/7 conventional dosing regimens. Communicating with women about these issues and contraceptive options is an ongoing process and does not end when the initial prescription is filled. As new contraceptive options become available, clinicians should discuss these with their patients. The use of a patient-centered approach (which focuses on informed decision making) allows clinicians to empower their patients to participate in decisions regarding OC use and may lead to successful OC use.

TECHNIQUES IN PATIENT-CLINICIAN COMMUNICATION REGARDING OCs: PATIENT-CENTERED APPROACH

Women should be active participants in the discussion about their use of OCs; they should be encouraged to ask questions and discuss their concerns. There are several models describing a patient-centered approach to informed decision making. Braddock et al.51 have proposed seven elements of informed decision making, of which six apply to OCs (Table 3). The elements focus on ensuring that the patient is made aware of his or her role in the decisionmaking process, discussing with the patient the clinical nature of the disease and various treatment options and their associated risks and benefits, and assessing patient understanding. Other counseling models have also been proposed,52,53 and across all these various models of patient communication, several common themes for implementation emerge: creating an open dialogue with the patient about the nature of the treatment being provided or condition being treated, discussing the risks and benefits of the various treatment options, ensuring that the patient understands what has been discussed, and asking about the patients treatment preferences.

ACKNOWLEDGMENT
I thank Jason McDonough, Ph.D., for technical assistance in the preparation of this paper.

REFERENCES
1. Sundell G, Milsom I, Andersch B. Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol 1990;97:588. 2. French L. Dysmenorrhea. Am Fam Phys 2005;71:285. 3. Fraser IS, McCarron G, Markham R. A preliminary study of factors influencing perception of menstrual blood loss volume. Am J Obstet Gynecol 1984;149: 788. 4. Chimbira TH, Anderson AB, Turnbull A. Relation between measured menstrual blood loss and patients subjective assessment of loss, duration of bleeding, number of sanitary towels used, uterine weight and endometrial surface area. Br J Obstet Gynaecol 1980; 87:603. 5. Westhoff C, Kaunitz AM. An overview of menstruation. Female Patient 2002;(Suppl Apr):4. 6. American College of Obstetricians and Gynecologists. ACOG Committee on Practice BulletinsGynecology. Premenstrual syndrome: Clinical management guidelines for obstetrician-gynecologists. ACOG Pract Bull 2000;15:448. 7. Freeman EW. Premenstrual syndrome and premenstrual dysphoric disorder: definitions and diagnosis. Psychoneuroendocrinology 2003;28(Suppl 3):25.

EXTENDED-CYCLE AND CONTINUOUS USE OF OC

8. Halbreich U. The etiology, biology, and evolving pathology of premenstrual syndromes. Psychoneuroendocrinology 2003;28(Suppl 3):55. 9. Halbreich U, Borenstein J, Pearlstein T, Kahn LS. The prevalence, impairment, impact, and burden of premenstrual dysphoric disorder (PMS/PMDD). Psychoneuroendocrinology 2003;28(Suppl 3):1. 10. Kraemer GR, Kraemer RR. Premenstrual syndrome: Diagnosis and treatment experiences. J Womens Health 1998;7:893. 11. Steiner M. Premenstrual syndromes. Annu Rev Med 1997;48:447. 12. Yonkers KA, Brown C, Pearlstein TB, Foegh M, Sampson-Landers C, Rapkin A. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol 2005;106:492. 13. Svalheim S, Tauboll E, Bjornenak T, et al. Do women with epilepsy have increased frequency of menstrual disturbances? Seizure 2003;12:529. 14. Herzog AG. Reproductive endocrine considerations and hormonal therapy for women with epilepsy. Epilepsia 1991;32(Suppl 6):S27. 15. Silberstein SD. Menstrual migraine. J Womens Health Gend Based Med 1999;8:919. 16. Silberstein S, Merriam G. Sex hormones and headache 1999 (menstrual migraine). Neurology 1999;53:S3. 17. MacGregor EA, Hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology 2004;63:351. 18. Martin VT. Menstrual migraine: A review of prophylactic therapies. Curr Pain Headache Rep 2004;8:229. 19. ACOG Committee on Practice BulletinsGynecology. ACOG practice bulletin. The use of hormonal contraception in women with coexisting medical conditions. Int J Gynaecol Obstet 2001;75:93. 20. Bhatia SC, Bhatia SK. Diagnosis and treatment of premenstrual dysphoric disorder. Am Fam Phys 2002;66: 1239. 21. Kaunitz AM. Oral contraceptive use in perimenopause. Am J Obstet Gynecol 2001;185:S32. 22. Dayal M, Barnhart KT. Noncontraceptive benefits and therapeutic uses of the oral contraceptive pill. Semin Reprod Med 2001;19:295. 23. The ESHRE Capri Workshop Group. Noncontraceptive health benefits of combined oral contraception. Hum Reprod Update 2005;11:513. 24. Kaunitz AM. Menstruation: Choosing whether . . . and when. Contraception 2000;62:277. 25. Speroff L, Darney PD. Oral contraception. A clinical guide for contraception, 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2005:21. 26. Sulak PJ, Scow RD, Preece C, Riggs MW, Kuehl TJ. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 2000;95:261. 27. Loudon NB, Foxwell M, Potts DM, Guild AL, Short RV. Acceptability of an oral contraceptive that reduces the frequency of menstruation: The tri-cycle pill regimen. Br Med J 1977;2:487. 28. Gladwell M. John Rocks error. The New Yorker March 13, 2000:52.

469

29. Sulak PJ. Contraceptive redesign: New progestins/ new regimens. J Fam Pract 2004;(Suppl):S3. 30. Mishell DR Jr. Rationale for decreasing the number of days of the hormone-free interval with use of lowdose oral contraceptive formulations. Contraception 2005;71:304. 31. Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: Randomized controlled trial. Obstet Gynecol 2001; 98:771. 32. Sulak PJ, Carl J, Gopalakrishnan I, Coffee A, Kuehl TJ. Outcomes of extended oral contraceptive regimens with a shortened hormone-free interval to manage breakthrough bleeding. Contraception 2004;70:281. 33. Edelman A, Gallo M, Jensen J, Nichols M, Schulz K, Grimes D. Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev 2005;3:CD004695. 34. Kwiecien M, Edelman A, Nichols MD, Jensen JT. Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose oral contraceptive: A randomized trial. Contraception 2003;67:9. 35. Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives. J Reprod Med 1995;40:355. 36. The ESHRE Capri Workshop Group. Ovarian and endometrial function during hormonal contraception. Hum Reprod 2001;16:1527. 37. Baerwald AR, Olatunbosun OA, Pierson RA. Ovarian follicular development is initiated during the hormone-free interval of oral contraceptive use. Contraception 2004;70:371. 38. Birtch RL, Olatunbosun OA, Pierson RA. Ovarian follicular dynamics during conventional vs. continuous oral contraceptive use. Contraception 2006;73:235. 39. Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception 2003;68:89. 40. 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. 41. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: A randomized trial. Obstet Gynecol 2003;101:653. 42. Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: Phase 3 study results. Contraception 2006;74:439. 43. Machado RB, Fabrini P, Cruz AM, Maia E, da Cunha BA. Clinical and metabolic aspects of the continuous use of a contraceptive association of ethinyl estradiol (30 microg) and gestodene (75 microg). Contraception 2004;70:365. 44. Cachrimanidou AC, Hellberg D, Nilsson S, Waldenstrom U, Olsson SE, Sikstrom B. Long-interval treatment regimen with a desogestrel-containing oral contraceptive. Contraception 1993;48:205.

470
45. Nelson AL. Extended-regimen contraception: Effects on menstrual symptoms and quality of life. J Fam Pract 2006;55:S1. 46. Stolley PD, Tonascia JA, Tockman MS, Sartwell PE, Rutledge AH, Jacobs MP. Thrombosis with low-estrogen oral contraceptives. Am J Epidemiol 1975; 102:197. 47. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med 2002;346:2025. 48. Sulak PJ, Kuehl TJ, Ortiz M, Shull BL. Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms. Am J Obstet Gynecol 2002;186: 1142. 49. Sulak PJ, Buckley T, Kuehl TJ. Attitudes and prescribing preferences of health care professionals in the United States regarding use of extended-cycle oral contraceptives. Contraception 2006;73:41. 50. Sulak PJ, Kuehl TJ, Coffee A, Willis S. Prospective analysis of occurrence and management of break-

NELSON
through bleeding during an extended oral contraceptive regimen. Am J Obstet Gynecol 2006;195:935. 51. Braddock CH III, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: Time to get back to basics. JAMA 1999;282:2313. 52. Miller J, Rollnick S. Motivational interviewing: Preparing people to change addictive behavior. New York: Guilford Press, 1991. 53. Mutha S, Allen C, Welch M. Toward culturally competent care: A toolbox for teaching communication strategies. San Francisco: Center for the Health Professions, University of California, San Francisco, 2002.

Address reprint requests to: Anita L. Nelson, M.D. 1457 3rd Street Manhattan Beach, CA 90509-2910 E-mail: AnitaLNelson@earthlink.net