With the recent developments in oral contraceptives, women now have a wide range of options from which to choose. Alterations in the traditional cyclic pill regimen—in which women take 21 days of hormonally active pills, followed by 7 days of placebos—are perhaps the most significant change. Extended-cycle and continuous oral contraceptives provide women with the option of reducing the frequency of menstruation or minimizing bleeding as well as significant health- and lifestyle-related benefits. Counseling patients on the risks and benefits associated with the different oral contraceptive options is important to help women choose an agent that best suits their individual needs and is safe for the individual patient. An interactive patient–physician relationship is likely to improve compliance, safety, and overall satisfaction with an oral contraceptive choice.

During the past decade, several new oral contraceptives (OCs) have become available that provide a wider range of options than the conventional 21/7 pill regimen (ie, 21 days of active pills, followed by 7 hormone-free days). These options include fewer hormone-free days and more time between hormone-free intervals. More than 40 OCs are currently available in the United States, including brand-name and generic products; all options and regimens maintain contraceptive efficacy as required by the US Food and Drug Administration. With such an array of choices, selecting the best fit for an individual woman can be challenging, but women now have the opportunity to choose an OC that closely suits their individual needs.

Physicians can play an important role in helping women choose an OC by providing them with an accurate assessment of the risks, benefits, side effects, and alternative contraceptive options. The World Health Organization has developed a classification of medical eligibility criteria in which the use of a given contraceptive method is categorized for specific medical conditions.¹ Physicians should be aware of risk factors and underlying medical conditions in which the potential risks of a specific OC usually outweigh its advantages, as well as conditions that represent an unacceptable health risk if a specific contraceptive method is used. The potential risks of hormonal contraceptives must also be weighed in light of the risks of pregnancy in women with some underlying medical conditions. The use of combination OCs is safe for the vast majority of reproductive-age women. The largest group of women who should not use OCs comprises smokers who are older than 35.

The Rationale for Extended-Cycle and Continuous OCs

The most significant change in OCs since their introduction more than 50 years ago has been the considerable reduction in hormonal dose, while maintaining contraceptive efficacy. Current OCs have much lower doses of estrogen and progestin. New administration schedules have recently been introduced, including extended-cycle and continuous use. When OCs were originally marketed, women were instructed to follow a 21/7 pill regimen that included a 21-day OC use and a 7-day interval, during which so-called withdrawal bleeding occurred, to minimize the perception that the OCs modified the menstrual cycle.² Indeed, most women consider such withdrawal bleeding to be their menstrual period; nevertheless, withdrawal bleeding is different from a menstrual period that results from the hormonal fluctuations of the hypothalamic-pituitary-ovarian axis.

OCs prevent pregnancy by suppressing ovulation through inhibition of the midcycle surge in the luteinizing hormone. Without ovulation, the corpus luteum is not formed, and the progesterone-induced glandular development that characterizes the luteal phase of the menstrual cycle does not occur. As a result, most women taking OCs have little or no newly proliferated endometrial tissue at the end of the third week of the pills,³ and the bleeding that women experience during the hormone-free interval is a direct result of hormone withdrawal, namely, a "false period."

Withdrawal bleeding is not necessary to maintain gynecologic health. Some women hold the misconception that if they do not have a period, blood or other "toxins" build up excessively. Other women desire a withdrawal period for reassurance of contraceptive efficacy, describing their period as a monthly "pregnancy test." Many women, however, may not know that eliminating withdrawal bleeding through extended or continuous use of OCs may have health- or lifestyle-related benefits.⁴

Long-term use of OCs has been successful in treating menstrual disorders and cycle-related conditions, including menorrhagia, dysmenorrhea, endometriosis, and iron-deficiency anemia.⁴ Women who are at risk for severe blood loss during their menses, including those with aplastic anemia, thrombocytopenia, von Willebrand's disease, or other blood dyscrasias, as well as those undergoing chemotherapy and/or bone marrow transplantation, will also benefit from menstrual suppression (Table 1).⁵

Extended-cycle or continuous OCs may offer relief from other cycle-related conditions, including premenstrual syndrome and premenstrual dysphoric disorder⁶; menstrual irregularity associated with perimenopause⁷; and disorders affected by menstruation, such as migraines without aura, catamenial seizures, and cyclic pelvic pain.⁸

In addition, all OCs provide noncontraceptive benefits, such as a reduced risk of certain medical conditions, including ovarian and endometrial cancers, benign breast disease, pelvic inflammatory disease, ectopic pregnancy, and functional ovarian cysts.⁹

A recent Cochrane review showed that extended-cycle and continuous OCs are as safe and effective as traditional 21/7 OCs, while also reducing the incidence of headaches, genital irritation, tiredness, bloating, and menstrual pain.¹⁰ Although no published studies have examined the use of OCs for longer than 2 years, no major concerns exist with regard to the long-term safety of extended-cycle and continuous OCs.¹¹

Endometrial biopsies after extended-cycle use reveal a persistently inactive or atrophic endometrium, without evidence of proliferation or hyperplasia.¹² Evidence also indicates that women using extended-cycle or continuous OCs are at a reduced risk for follicular development associated with missed pills before or after the traditional hormone-free interval.¹³ For many women, follicular development begins by the seventh day of the hormone-free pills; extended-cycle regimens thus minimize the monthly risk of follicular development and the potential for escape ovulation.¹⁴

Effective Dialogue with the Patient

Effective patient–physician communication is important in evaluating the best OC fit for an individual. Patients are more satisfied with the care they receive if they perceive that their physician communicates willingly and effectively.¹⁵ Patients who feel their physician listened to their concerns and questions are less likely to contact him or her again later. Furthermore, allowing patients to express their concerns has not been shown to prolong examination time. Accordingly, physicians who believe that the psychosocial aspects of patient care are important have been shown to be more effective at communicating with their patients.¹⁶

Informed consent: the BRAIDED mnemonic
The initial step in helping women choose an OC is to explore their expectations for a birth control method and identify features that would make a specific method more appealing (eg, discretion, noncontraceptive benefits, pill regimen). Regulations issued by the US Department of Health and Human Services focus on the principle of informed consent, which consists of 7 basic elements that have been summarized in the mnemonic BRAIDED (Table 2).¹⁷ Using this mnemonic will help you recall all these elements. The goal is to reach an informed decision that is voluntary on the patient's part, not coerced.

Major considerations
Key issues that should be addressed with the patient during the discussion of OC options include:

• All OC agents impart similar contraceptive efficacy, and normal fertility returns rapidly once OCs are discontinued.¹⁸
• Evidence indicates that fertility returns rapidly after discontinuation of a continuous OC regimen.¹⁹
• All OCs confer menstrual benefits, including reduced bleeding and enhanced cycle regularity.
• The degree of improvement for individual symptoms may vary according to OC dose, formulation, and regimen, as well as among individual women.¹⁸

Associated risks, warning signs
Physicians should discuss with their patients the specific medical risks, such as venous thromboembolism, that are associated with all OCs, as well as factors that may increase the risks of OC use, such as age, family history, personal medical history, smoking, and obesity.

Medical conditions that make the risk of OC use unacceptably high include uncontrolled hypertension, known thrombogenic mutations, migraines with aura, breast cancer, active liver disease, and a history of stroke or venous thromboembolism, including deep-vein thrombosis (DVT) and pulmonary embolism.¹ The risks are also higher for women older than 35 years who smoke, and these women should not use combination hormonal contraceptives.

Women should be made aware of certain symptoms that may signify trouble. These warning signs, which can be referred to by the mnemonic ACHES, are⁹:

• Abdominal pain: severe. OC use can increase the risk of liver tumors, pancreatitis, or gallbladder disease; all are rare conditions.
• Chest pain: severe; cough, shortness of breath, or sharp pain on breathing in. Women taking combination OCs have a 3- to 5-fold increased risk of venous thromboembolism phenomena, including an increased risk of pulmonary embolism, although the baseline risk of venous thromboembolism in young, healthy women is low.
• Headache: severe; dizziness, weakness, or numbness, especially if one-sided. Women taking OCs have a small increased risk of ischemic stroke, but the background risk of stroke among women at reproductive age is low.
• Eye problems: vision loss/blurring; speech problems. These symptoms can be signs of a stroke.
• Severe leg pain: calf or thigh. One-sided leg pain can be associated with DVT.

Women who experience any of these symptoms during OC use should contact their physician immediately. Specifically, headaches, weakness or numbness, visual problems, and speech problems may signify stroke. Symptoms of pulmonary embolism include cough, chest pain, and shortness of breath. Severe swelling and pain of the calf or thigh serve as warning signs of DVT. The annual incidence of venous thromboembolism is approximately 4 cases for every 100,000 women among nonusers of OCs; 10 to 30 cases for every 100,000 women among users of combination OCs; and 60 cases for every 100,000 women among pregnant women. Therefore, pregnancy poses a 2- to 6-fold greater risk of venous thromboembolism than does OC use.

OCs for older women
Although OCs are safe for healthy nonsmokers until they reach their mid-50s, many women hold the misconception that OC use poses increased risk after the age of 35.⁷ The use of OCs remains a viable option for all women, including those over age 35, unless they smoke, have a personal history of hypertension or diabetes, or a family history of cardiovascular disease.

Aside from protection against unintended pregnancy, OCs may offer specific benefits for older women as they enter the menopause transition, including protection against bone loss and endometrial and ovarian cancers, as well as relief from perimenopausal symptoms, such as menstrual irregularities and hot flashes.⁷

Common side effects
Physicians should address with their patients common adverse events that are associated with OC use. For instance, patients should be instructed to use secondary contraception in the event of missed pills. Patients should also be counseled on the possibility of breakthrough bleeding, which is common with most OCs during the first 3 pill packs.

Physicians should also ascertain whether patients have heard about extended-cycle or continuous OCs to gauge their interest in these newer regimens. Women who may be considering extended-cycle or continuous OCs should be counseled on the possibility of irregular bleeding patterns that may last for longer than 3 to 4 months and occur at initially higher rates.^20,21 Women who are willing to tolerate some unscheduled bleeding may be the most suitable candidates for continuous OC use.

Interest in extended-cycle or continuous regimens may vary, depending on a variety of factors, such as reproductive stage and lifestyle preferences. A number of studies have assessed women's attitudes toward the frequency and characteristics of menses; these studies have shown that many women are interested in menstrual suppression. In general, older women are more interested in extended-cycle or continuous regimen options than are younger women.²² A survey of military women indicated that 49% were interested in menstrual suppression.²³ Women with certain lifestyles, such as dancers or athletes, may also prefer a reduced frequency of menstruation.

Clinical studies comparing bleeding profiles observed with 21/7 cyclic OCs and with continuous OCs indicate that the overall number of bleeding days is lower with continuous use.^19,20 One study randomly assigned 32 women to take levonorgestrel 100 µg/ethinyl estradiol 20 µg for 6 conventional cycles or continuously for 168 days.¹⁹ The mean total bleeding days (including planned and unplanned bleeding) was 25.9 and 34.9, for the continuous and cyclic groups, respectively. Aside from having fewer days of bleeding/spotting, women taking the continuous OC regimen also reported a reduced level of menstrual pain and bloating.¹⁹

Many women gradually achieve amenorrhea with continuous OC regimens. In a study of more than 2000 women who received 13 pill packs of a continuous OC (levonorgestrel 90 µg/ethinyl estradiol 20 µg), 44.8% had amenorrhea when assessed at pill pack 7, and 58.7% had amenorrhea at pill pack 13.²¹ Women considering a continuous OC regimen should be advised of the possibility of amenorrhea and the lack of a cyclic withdrawal period.

Women should be informed of factors that have the potential to increase the occurrence of breakthrough bleeding and possibly impair contraceptive efficacy. Evidence suggests that missing pills correlates with a higher incidence of breakthrough bleeding.²⁴

Smoking has also been shown to increase breakthrough bleeding, and impaired contraceptive efficacy has been postulated.²⁵ In addition, the use of OCs with liver enzyme–inducing drugs (ie, anticonvulsants) is known to reduce contraceptive efficacy; in such cases, OC doses should be increased and the use of a backup contraceptive method advised.⁹

Follow-up
Patients should be encouraged to ask questions, raise concerns, and keep a menstrual calendar (regardless of whether they are taking cyclic or extended-cycle/continuous OCs), which they should bring to the next appointment. Physicians should advise patients to schedule a follow-up appointment within 6 to 12 weeks after the initial appointment to address concerns and side effects, discuss proper use, document weight and blood pressure, and assess overall satisfaction. One study showed that women are most likely to discontinue OCs in the first 2 months after initiating pill use.²⁶ An interactive patient–physician relationship is important, considering that most women discontinue OCs without telling their physician.²⁷ Ensuring that patients understand how to properly use their OCs and what to expect from them is likely to improve adherence. It has also been shown that patients' satisfaction with their OC choice is high among those who have received thorough counseling from their physician.²⁴

Conclusion

Women now have access to many new OC choices. Extended-cycle and continuous OCs represent important new options. With the wide range of OC options currently available, it is crucial that physicians be aware of medical conditions that present an unacceptable health risk for the use of combination OCs. For the large majority of women, however, for whom OC benefits outweigh the potential risks, it is important that clinicians communicate effectively about possible side effects and benefits associated with their OC choice.

Disclosure Statement

Dr Hillard is a consultant to and on the Scientific Advisory Board of GlaxoSmithKline, Merck, Procter & Gamble, and Wyeth-Ayerst; receives research support from Duramed; and is on the Speaker's Bureau of and receives honorarium from 3M, Association of Reproductive Health Professionals, Barr, Berlex, Merck, Pfizer, Pharmacia-Upjohn, Organon, Ortho-McNeil, TAP, and Wyeth-Ayerst. Dr Rath has nothing to declare.

SELF-ASSESSMENT TEST

1. Which of the following statements about extended-cycle or continuous OCs, compared with traditional 21/7 OCs, is not true?

1. They have a lower estrogen content
2. They reduce the incidence of bloating
3. They reduce the incidence of menstrual pain
4. They are equally effective in preventing pregnancy

2. All these are elements of informed consent that must be addressed when discussing OC options, except:

1. Describing benefits of the method
2. Describing alternatives to the method
3. Discussing the need for adherence
4. Allowing the patient to discontinue the treatment without penalty

3. Which of these conditions is a contraindication to OC use in a 25-year-old woman?

1. Obesity plus smoking
2. Type 2 diabetes
3. Hyperlipidemia
4. Migraine with aura

4. Women taking OCs should contact their physician immediately if they have any of these symptoms, except:

1. Blurred vision
2. Insomnia
3. Pain in one leg
4. Severe chest pain

5. The use of OCs to achieve therapeutic amenorrhea is not appropriate in which one of the following conditions?

1. Hemophilia
2. Endometriosis
3. Moderate mental retardation
4. Stroke

(Answers at end of references list)

References

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2. Loudon NB, Foxwell M, Potts DM, et al. Acceptability of an oral contraceptive that reduces the frequency of menstruation: the tri-cycle pill regimen. Br Med J. 1977;2:487-490.
3. ESHRE Capri Workshop Group. Ovarian and endometrial function during hormonal contraception. Hum Reprod. 2001;16:1527-1535.
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8. Nelson AL. Extended-cycle oral contraception: a new option for routine use. Treat Endocrinol. 2005;4:139-145.
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19. Kwiecien M, Edelman A, Nichols MD, et al. Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose oral contraceptive: a randomized trial. Contraception. 2003; 67:9-13.
20. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653-661.
21. Archer DF, Jensen JT, Johnson JV, et al. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol. Contraception. 2006; 74:439-445.
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Answers: 1. A; 2. C; 3. D; 4. B; 5. D.