Hormonal Contraception: The Challenges Ahead

WHEC Practice Bulletin and Clinical Management Guidelines for healthcare providers. Educational grant provided by Women's Health and Education Center (WHEC).

For many women, safe and effective hormonal contraception is a mainstay of successful pregnancy planning and a source of important non-contraceptive benefits. Several new formulations and delivery systems for hormonal contraception offer long-term, non-daily, reversible alternatives to daily oral regimes. The availability of these new products and the continued viability of the older hormonal and non-hormonal methods allow physicians to individualize therapy according to patients' needs and preferences. However, the range of hormonal contraception options raises questions about which method and mode of administration may be most appropriate for a particular woman. Worldwide, hormonal contraceptives have been a part of clinical practice for more than 40 years, and family planning programs, based largely on contraceptive provision, are regarded as one of the most successful public health interventions of the 20th century. Currently, the rate of unplanned pregnancies in the United States remains at epidemic levels, accounting for almost half of all pregnancies. In terms of cost-effectiveness, prevention of unplanned pregnancies through contraceptive use has repeatedly been shown to be a highly cost-effective use of health care dollars. Fortunately, over time, options for effective contraception have expanded and the overall risks associated with hormonal contraceptives have been reduced as compared with older formulation, even for women with medical conditions. Many modern hormonal contraceptives also offer valuable non-contraceptive benefits.

The purpose of this document to summarize both technical and programmatic aspects of hormonal contraceptive use. The methods of hormonal contraception are discussed in order of efficacy from highest to lowest. We hope to help healthcare providers in clinical decision making regarding hormonal contraception use in their population and to identify and discourage the unnecessary practices, tests and procedures. Facilitating contraceptive use and reducing barriers to contraceptive provision are also discussed. The public is often aware of the risks of hormonal contraceptives that are all-too-often described by sensational reports in media; these drugs remain among the most studied products on the market, helping millions of women worldwide to safely and effectively prevent unintended or unplanned pregnancy.

Background:

Package labeling approved by the U. S. Food and Drug Administration (FDA) for progestin-only contraceptives is in some cases the same as that for combined estrogen-progestin methods without supporting evidence, further complicating decisions for women with coexisting medical conditions. For instance, current labeling for norethindrone progestin-only oral contraceptives no longer lists a history of thromboembolism as a contraindication. Such a history, however, remains listed as a contraindication in package labeling for norgestrel progestin-only pills and for depot medroxyprogesterone acetate (DMPA) injections. Healthcare providers should understand that other non-hormonal forms of contraception, such as the copper intrauterine device (IUD), remain safe, effective choices for many women with medical conditions (1). Because the transdermal and vaginal ring combination hormonal contraceptives are new, little if any data address their safety in women with underlying medical conditions. In the absence of specific evidence to the contrary, contraindications to the use of combination oral contraceptives also should be considered to apply to these newer combination methods. Exogenous estrogen increases synthesis of several coagulation factors that promote thrombosis, in dose-dependent manner (2). There is no increased risk of arterial thrombosis (myocardial infarction [MI], stroke) in non-smoking, normotensive women using estrogen-containing (combination) methods compared with non-users. However, in women with preexisting thrombotic risk factors the risk of thrombosis is further increased by combination hormonal method use.

Definitions used in epidemiologic studies:
Low-dose oral contraceptives -- products containing less than 50 µg ethinyl estradiol
First-generation oral contraceptives -- products containing 50 µg or more of ethinyl estradiol
Second-generation oral contraceptives -- products containing levonorgestrel, norgestimate, and other members of the norethindrone family and 20, 30 or 35 µg ethinyl estradiol
Third-generation oral contraceptives -- products containing desogestrel or gestodene with 20, 25, or 30 µg ethinyl estradiol

Pharmacology of Steroid Contraception:

The estrogen component of combination oral contraceptives -- estradiol -- is the most potent natural estrogen and is the major estrogen secreted by the ovaries. The major obstacle to the use of sex steroids for contraception was inactivity of the compounds when given orally. A major breakthrough occurred in 1938 when it was discovered that the addition of an ethinyl group of the 17 position made estradiol orally active. Ethinyl estradiol is a very potent oral estrogen and is one of the two forms of estrogen in every oral contraceptive. The other estrogen is the 3-methyl ether of ethinyl estradiol, mestranol. Mestranol and ethinyl estradiol are different from natural estradiol and must be regarded as pharmacologic drugs. In human body, differences in potency between ethinyl estradiol and mestranol do not appear to be significant, certainly not as great as indicated by assays in rodents. This is now a minor point because all of the low-dose oral contraceptives contain ethinyl estradiol. The estrogen content (dosage) of the pill is of major clinical importance. Thrombosis is one of the most serious side effects of the pill, playing a key role in the increased risk of death (in the past with high doses) from a variety of circulatory problems (3).

New Progestins: Probably the greatest influence on the effort that yielded the new progestins was the belief throughout the 1980s the androgenic metabolic effects were important, especially in terms of cardiovascular disease. The new progestins include desogestrel, gestodene, and norgestimate, and even newer progestins are in development. All progestins derived from 19-nortestosterone have the potential to decrease glucose tolerance and increase insulin resistance. The impact on carbohydrate metabolism of the previous low-dose formulations was very minimal, and the impact of the new progestins is negligible. The decrease androgenicity of the progestins in the new products is reflected in increase sex hormone-binding globulin and decreased free testosterone concentrations to a greater degree than the older contraceptives. This difference could be of greater clinical value in the treatment of acne and hirsutism. The new progestins, because of their reduced androgenicity, predictably do not adversely affect the cholesterol-lipoprotein profile. Indeed, the estrogen-progestin balance of combined oral contraceptives containing the new progestins may even promote favorable lipid change. Drospirenone is a progestin that is an analogue of spironolactone. Its biochemical profile is very similar to progesterone, including a high affinity for the mineralocorticoid receptor that produces an antimineralocorticoid effect. Because drospirenone is spironolactone-like with antiandrogenic and antimineralocorticoid activity, caution is recommended in regard to serum potassium levels, avoiding its use in women with abnormal renal, adrenal, or hepatic function (4).

Hormonal Contraception and Venous Thromboembolism Risk:

Venous thromboembolism (VTE) is a rare event in young reproductive age women. According to World Health Organization (WHO) data compiled for developed countries in 1997, the VTE event rates per 10,000 woman-years among non-pregnant women 20 to 24 years, 30 to 34 years, and 40 to 44 years of age who are not using combination hormonal contraception are 0.32, 0.46, and 0.59, respectively. More recently, the European Agency for the Evaluation of Medicinal Products estimated that the rate of VTE in healthy non-pregnant women not using combination hormonal contraception is 0.5 to 1.0 per 10,000 woman-years, and a systematic review of published incidence rate of VTE (defined as deep vein thrombosis and/or pulmonary embolism) found that the incidence of VTE in community and cohort studies of non-pregnant reproductive-age women was substantially higher -- 5 to 10 per 10,000 woman-years (5). The higher VTE incidence found in recent reports likely reflects, in large part, improved diagnostic approaches to VTE, particularly enhanced imaging techniques. Differences in the reported incidence of VTE may also reflect variable risk factors present in the population under investigation, because the interaction of both genetic and acquired characteristics affects an individual's likelihood of experiencing an event.

Risk Factors for VTE: The risk is increased among women with a personal history of VTE or VTE in a first-degree relative. Women with familial coagulation disorders, including factor V Leiden mutation, prothrombin G20210A mutation, deficiencies of anticoagulant proteins (antithrombin, protein C, protein S), and elevations in procoagulant factors (factor VIII, factor IX, factor XI), are 2 to 8 times more likely to experience a VTE event than are unaffected individuals (6). VTE risk increases substantially with increasing age and may increase somewhat with cigarette smoking or hypertension. In the past, diabetes was not considered a major risk factor for VTE; however, recent population-based studies have found that the risk of VTE is 1.5 to 2.3 times greater in individuals with diabetes than in those without. Women who are obese (body mass index [BMI] >30 kg/m2) have a 2- to 5-fold increased risk of VTE compared to that of women of normal weight (BMI <25 kg/m2). Other factors associated with an increased risk of VTE include prolonged immobilization or recent major surgery, prolonged air travel, and autoimmune disease (eg, systemic lupus erythematosus). The risk of VTE is markedly elevated during pregnancy and puerperium. It is estimated VTE event rate during the puerperium is about 2 to 5 times greater than during pregnancy.

Putting VTE risks in perspective -- Absolute vs Attributable risk: When discussing the risk rate of rare events, including VTE risk, using absolute or attributable risks may be more appropriate than focusing on relative risks (7). Women with VTE risk factors and their healthcare providers must weigh the benefits of preventing unintended pregnancy against the risk of using combination hormonal contraception. Mortality during pregnancy or postpartum is also a consideration. There has been considerable debate about whether all women considering use of combination hormonal contraception should be screened for thrombophilias. Currently, the American College of Obstetricians and Gynecologists (ACOG) and others do not recommend such testing prior to use of birth control pill, for a number of reasons. First, whether used alone or in combination, the available coagulation tests do not have sufficient specificity to predict who will develop VTE, and the cost of widespread testing is prohibitive. A positive test does not mean that a woman will develop VTE if she uses combination hormonal contraception, and a negative test does not guarantee that she will not. Second, these mutations are uncommon. The factor V Leiden mutation occurs in about 5% of the Caucasian population (ie, Europeans, Jews, Israeli Arabs, and Indians), and the prothrombin G20210A mutation occurs in about 2%. Both mutations are very rare in Africans or Asians. Third, a large number of women would have to be screened to have any impact on VTE morbidity and mortality -- it is estimated; to prevent one death it might be necessary to screen more than 2 million women.

Incidence of Unscheduled Bleeding / Spotting:

Studies have shown that bleeding irregularities in the first few months of hormonal contraceptive use are among the most common reasons for premature method discontinuation. Women discontinuing hormonal method use because of unscheduled bleeding may substitute a less effective contraceptive method or no method, increasing their risk of unintended pregnancy. The US Food and Drug Administration (FDA) does not evaluate bleeding / spotting data as part of safety or efficacy evaluations of new contraceptive products. Furthermore, there is no standardization of methods for collecting or of criteria for analyzing bleeding / spotting data in clinical data (8). Although study findings are not directly comparable, clinicians should be familiar with the reported cycle control profiles of various contraceptive methods in order to inform and counsel women considering use.

Combination Hormonal Methods

Bleeding patterns differ according to hormonal formulation, such as estrogen-progestin formulation, such as estrogen dose, type and dose of progestin, estrogen-progestin ratio, phasing; and regimen (eg, number of days of active tablets / inactive tablets, route of administration).

Combination Oral Contraceptives (COCs): Because of the lack of uniformity in reporting data, COC formulations studied separately cannot be reliably compared; few direct comparisons of different formulations in the same trial are available. One systematic review assessed randomized controlled trials comparing women using a COC containing 20 mcg or ethinyl estradiol (EE) with those using a COC containing more than 20 mcg up to 35 mcg EE. More 20-mcg-EE users discontinued COC use and had more bleeding pattern disruptions (including unscheduled bleeding) than did users of COC's containing more than 20 mcg EE (8, 9). With COCs containing more than 20 mcg EE, unscheduled bleeding / spotting most commonly occurs in the first 2 to 3 months or use; incidence ranges from 10% to 30% of participants in the first month to less than 10% in the third month, and disappears in the majority of women by the third month of use (9). Oral contraceptive users who had 24 days of drospirenone 3 mg / EE 20 mcg and 4 days of placebo experienced more improvement in premenstrual disorders, especially premenstrual dysphoric disorder (PMDD) symptoms with the oral contraceptive than with placebo. Oral contraceptive users who had desogestrel 150 mcg / EE 20 mcg followed by 2 hormone-free days and then 5 days of EE 10 mcg had a larger reduction in dysmenorrhea in comparison with placebo users.

Extended-use COC Regimens: In a parallel, randomized, multicenter 1-year study, an extended-use regimen (84 days of active hormones, 7 days of placebo) of a 30 mcg EE / 150 mcg levonorgestrel (LNG) COC decreased the number of scheduled bleeding episodes compared with a conventional 28-day regimen of COC containing the same formulation. However, the median number of unscheduled bleeding and / or spotting days with extended-use COC was found to be 26 of 336 possible (ie, occurring during the active-tablet interval) unscheduled bleeding days compared with a median number of 13 of 273 possible unscheduled bleeding days with conventional regimen. The number of unscheduled bleeding and / or spotting days with use of this COC decreased from a median of 5 in the first 91-day cycle of use to 2 in the final 91-day cycle of a 2-year extension trial (10). In a prospective, multicenter, uncontrolled study of women switching from a 28-day cycle to an off-label 126-day extended regimen of a 30 mcg EE / 3 mg drospirenone-containing COC, 40% of the 177 women reported no bleeding during the 126-day study period, while 60% of the women reported at least 1 unscheduled bleeding day; typically, the bleeding was mostly light in intensity (20).

Extended and Continuous Regimens: These have been found to improve menstrual associated symptoms and lessen the overall number of bleeding days. Unscheduled bleeding or spotting is a common problem and one of the main reasons for pill discontinuation with regimens dosed in an extended or continuous fashion, but it seems to improve with duration of use.

FDA-Approved Extended and Continuous Regimens (20)

Brand Name

Manufacturer

Estrogen Dose

Progestin Dose

Regimen

Seasonale

Barr Laboratories, Inc. (Pomona, NY)

30 micro g of EE

150 micro g of LNG

Continuous 84 active pills/7 placebo pills

Seasonique

Barr Laboratories, Inc. (Pomona, NY)

30 micro g of EE

150 micro g of LNG

Continuous 84 active pills/7 pills, 10 micro g of EE

Lybrel

Wyeth Pharmaceuticals, Inc. (Philadelphia, PA)

20 micro g of EE

90 micro g of LNG

Continuous LNG/EE

Yaz

Bayer Schering Pharma AG (Leverkusen, Germany)

20 micro g of EE

3 mg of  DRSP

Extended 24 active pills/4 placebo pills

Loestrin 24 Fe

Warner Chilcott, Inc.

(Rockaway, NJ)

20 micro g of EE

1 mg of NET

Extended 24 active pills/4 placebo pills

EE: ethinyl estradiol; LNG: levonorgestrel; DRSP: drospirenone; NET:norethindrone.

Transdermal Contraceptive Patch: Pooled data from clinical trials of the transdermal contraceptive patch (delivering 20 mcg EE / 150 mcg norelgestromin daily), including 2 randomized trials comparing the patch with a COC (30 mcg EE / triphasic LNG or 20 mcg EE / desogestrel) and 1 non-comparative trial were analyzed (11). Incidence of unscheduled bleeding (defined as bleeding over more than 1 pad or tampon per day) and spotting decreased over time from cycle 1 (~18%) to cycle 13 (~10%), with no statistical difference in incidence of unscheduled bleeding days between patch users and comparator COC user at any cycle in the pooled data. In one of the comparative trials, rates of unscheduled trials, rates of unscheduled bleeding and / or spotting were significantly (p-value not given) higher with the patch than with the COC in cycles 1 and 2 only but did not differ significantly from the COC rates in subsequent cycles (12). No studies have examined the effect of the patch on dysmenorrhea or premenstrual disorders.

Vaginal Ring: In a randomized trail comparing the combination hormonal vaginal ring (releasing 15 mcg EE / 120 mcg of etonogestrel daily) with a 30 mcg EE / LNG-containing COC, the incidence of cycles with unscheduled bleeding (requiring >2 pads or tampons per day) was lower (1.1%-5% per cycle) with the ring than with the COC (5.4%-38.8% per cycle) over 6 cycles of use (13). Despite the ring's low level of EE, this method provides excellent cycle control from the initiation of use; incidence of unscheduled bleeding during cycle 1 was significantly lower (1.9% vs 38.8%; p<.001) with the ring than with the COC. In an open-label controlled trial of the ring and a 25 mcg EE / norgestimate-containing COC, the mean number of bleeding / spotting days with the ring was 4 fewer than with the COC (17.0 vs 21.4) in the first 3 cycles of use. No studies have been conducted to examine the effect of the ring on dysmenorrhea or premenstrual disorders.

Progestin-Only Methods

Use of progestin-only contraceptives almost invariably causes unscheduled bleeding in at least in at least the first year of use, a major reason for premature discontinuation of these methods.

Progestin-only Oral Contraceptives: Approximately 60% of cycles are irregular during the first 6 months of progestin-only oral contraceptive use, and 47.5% of women discontinuing use of this method do so because of menstrual disturbances (3). With longer use, women can expect to have normal ovulatory cycles (40%-50%); short irregular cycles (40%); or mixtures of bleeding, spotting, and amenorrhea (10%).

Depot Medroxyprogesterone Acetate (DMPA): With use of either intramuscular or subcutaneous DMPA, any bleeding or spotting that occurs is unscheduled; both bleeding and spotting are frequent during the first 3 months of DMPA use but decrease progressively with each subsequent quarterly injection. Incidence of unscheduled bleeding / spotting days with DMPA use is approximately 70% in the first year and 10% thereafter (3, 14). About 50% of DMPA users are amenorrheic by 1 year of use and about 70% by 2 years of use (14).

Single-rod Etonogestrel (ENG) Implant: Unscheduled bleeding is very common throughout use of the single-rod 3-year ENG implant. An open, multicenter, 3-year study of implant use found that during the first 90-day reference period of implant use, 40.2% of users experienced prolonged bleeding (at least 1 bleeding / spotting episode starting within a 90-day reference period and lasting more than 14 days); 11.5% experienced frequent bleeding (more than 5 bleeding / spotting episodes starting within a 90-day reference period, excluding amenorrhea); and 0.9% or 555 women experienced amenorrhea (no bleeding or spotting throughout a 90-day reference period. Unlike bleeding patterns with the 6-rod LNG implant (no longer available in the United States), which become more regular with increasing duration of use, bleeding patterns with the ENG implant do not improve substantially with longer duration of use (15). After 3 years of ENG implant use, 22.1% of 122 women had prolonged bleeding, 3.3% had frequent bleeding, and 29.5% had infrequent bleeding (15). Bleeding irregularities (not including amenorrhea) are a major reason for discontinuation (17.2%) of ENG implant use during the first 2 years of use; accordingly, candid pre-insertion counseling is necessary to help women anticipate this side effect.

Levonorgestrel Intrauterine Contraceptive (LNG-IUC): With continued use (longer than 6 months), the LNG-IUC reduces the amount of vaginal blood loss in almost all users, decreases the number of bleeding / spotting days, and increases the incidence of amenorrhea (<20%-50% at year 1, up to 70% at end of Year 2). However, in the first few months of use, LNG-IUC users experience frequent episodes of unscheduled bleeding and spotting (16). Women initiating LNG-IUC use require detailed counseling about the expected eventual improvement in bleeding patterns to help prevent premature and unnecessary method discontinuation. Women who use the LNG-IUC have 2 concurrent changes in bleeding patterns. First, they may have an increase in unscheduled breakthrough spotting which resolves 4 to 6 months after insertion. Second, there are decreases in number of menstrual bleeding days and amount of menstrual blood loss. Amenorrhea rates are also high among LNG-IUC users -- 20% after 1 year and 30% to 50% after 2 years. Dysmenorrhea and pelvic pain also decreases with LNG-IUC use (16).

Clinical Decision-Making:

If a woman using combination hormonal contraception experiences continued episodes of unscheduled bleeding after the first 3 to 4 months of use, intracavitary lesions, endometrial cancer, cervical cancer, cervicitis, infection, and pregnancy should be ruled out. If patients experience premenstrual irritability PMDD; consider prescribing drospirenone / EE 24 / 4 oral contraceptive. If patient prefers not to have menses at all, consider using an extended-regimen oral contraception or extending cycles with the patch or ring. Patients needing for long-acting method may be good candidate for either the LNG-IUC or medroxyprogesterone acetate. After 6 months or more of LNG-IUC use, persistent or recurrent bleeding is frequently associated with an intracavitary myoma or endometrial polyp. Hysteroscopy, pelvic ultrasonography, or saline infusion sonography should be considered in such women.

Counseling:

To lessen the impact of any unscheduled bleeding or spotting that may occur, women considering use of hormonal use of hormonal contraceptives should be made aware before initiating method use of the possibility and likely duration of these effects. An appropriately counseled woman who understands in advance that unscheduled bleeding commonly occurs during the first few months of use of any combination hormonal contraceptive method is more likely to accept this transient effect without method dissatisfaction. She is, therefore, less likely to discontinue method use prematurely than women who do not receive such anticipatory guidance (3, 8, 9, 16). Anticipatory guidance is particularly important for women considering use of all progestin-only methods, as unscheduled bleeding and spotting may persist with these methods for longer durations than with combination methods. Women should be strongly encouraged to all the clinician before discontinuing method use. If unscheduled bleeding or spotting does occur and is perceived as troublesome, counseling should be repeated along with renewed reassurance that these effects do not compromise safety or contraceptive effectiveness. Persistent complaints or abnormal bleeding should prompt an office visit with clinical evaluation. Method-specific instructions should be provided regarding what to do in case of missed or incorrect contraceptive use. Cigarette smoking is likely to increase the risk of unscheduled bleeding with hormonal contraceptive use. Users of these methods should be encouraged to stop smoking for overall health reasons.

Sociocultural and Multicultural Issues in Contraceptive Counseling:

As the United States population becomes increasingly heterogeneous, sociocultural and multicultural factors become key to clinical effectiveness in many health care encounters. Widely diverse ethnic and/or cultural values, beliefs, attitudes, practices, and interpersonal styles influence both clinicians and patients, making more complex the process of providing health services responsive to patient needs. In many cultures family decision making is valued, and it is traditional for more than one person in a family to be involved in such important decisions as medical ones. Decisions may be deferred until the family can confer and arrive at a conclusion. Contraceptive and other reproductive / sexual decision making as well as adherence to contraceptive regimens also may involve other individuals who have a major influence upon specific women's lives. Linguistic access to care is an integral part of cultural competence in healthcare. Absence of interpreter services or culturally / linguistically appropriate health education materials is associated with patient dissatisfaction, poor comprehension and treatment adherence, and ineffective or lower-quality care. Clinicians need to assess their own attitudes and beliefs regarding cultural values and cultural stereotyping before determining approaches to women of different ethnicities and / or cultures (19).

The rate of unintended pregnancy in the United States remains high, and misinformation about the benefits and risks of contraceptive methods contributes substantially to that result. While clinicians make many positive efforts to address and correct misperceptions about contraception, the growing multicultural heterogeneity of the US population -- particularly among reproductive-age women, constitutes an additional challenge. Diverse ethnic and cultural values and practices, as well as interpersonal styles of interaction, make the process of providing health services responsive to women's needs a complex endeavor. Cultural and linguistic factors may affect many women's ability to select and successfully use appropriate contraception to prevent unintended pregnancy. Clinicians need to recognize and respond sensitively to cultural differences, as well as to individual characteristics, in family planning attitudes, contraceptive decision making, and language.

Therapies:

A variety of therapies may be useful in decreasing number of episodes, number of days, and / or quantity of unscheduled bleeding / spotting. These agents should be initiated when bleeding begins and taken only while bleeding continues.

Non-Hormonal Agents: Non-steroidal anti-inflammatory drugs (NSAIDs), including mefenamic acid (500 mg every 6 hours), ibuprofen (400 mg every 8 hours), naproxen (400 mg per day), and naproxen sodium (220 mg per day), have shown to reduce the incidence of unscheduled bleeding and amount of blood loss. Doxycycline (100 mg every 12 hours) also has been found to effectively decrease unscheduled days and episodes, particularly in women using progestin-only or progestin-dominant contraceptive method (17). Antifibrinolytic agents (ie, epsilon-aminocaproic acid 500 mg every 6 hours, tranexamic acid, 1 g every 6 hours), also have been found to effectively reduce mean blood loss. Although tablet forms of these agents have been approved in the United States for other indications, they are not approved for management of unscheduled bleeding during hormonal contraceptive use and are associated with side effects such as nausea and dizziness.

Hormonal Therapies: When unscheduled bleeding occurs in users of combined hormonal contraceptives, the ENG implant, or DMPA, a 7-day course (when bleeding is present) or conjugated estrogens 1.25 mg or estradiol 2 mg is usually effective; subsequent recurrence of unscheduled bleeding is uncommon (18). However, neither evidence nor biologic plausibility supports the use of estrogen therapy in LNG-IUC users experiencing unscheduled bleeding / spotting, as exogenous estrogen does not counteract the local effect of LNG on the endometrium. For unscheduled bleeding or spotting during extended-use COC regimens, one group of investigators has suggested that a 3-day hormone-free interval-initiated when bleeding / spotting begins -- may be effective in ameliorating the problem (18). The hormone-free interval should be implemented no more frequently than every 3 weeks to maintain contraceptive effectiveness.

Summary:

During contraceptive method selection, explore with each woman her childbearing intentions, lifestyle, contraceptive history, and any specific concerns about contraceptive methods. Use open-ended questions and listen to, acknowledge, and address responses. If unscheduled bleeding or spotting occurs, repeat counseling and reassurance about transience and management of this effect should be considered. Reassuring woman about safety and contraceptive effectiveness and reinforcing importance of calling before discontinuing method use if problem becomes unacceptable are quite helpful. Hormonal contraceptive methods are safe and effective for majority of women. Users of combination hormonal methods should be reassured that unscheduled bleeding / spotting is usually transient, resolving after 3 months of use. Potential users of progestin-only methods need to know that unscheduled bleeding occurs almost universally with use of these methods. Emphasize that unscheduled bleeding / spotting comprises neither safety nor contraceptive effectiveness. Candidly discuss woman's perception of pros and cons of each method. Many patient education materials are available in Spanish but fewer are available in other languages. Clinicians can explore the possibilities of providing reproductive-health and contraceptive-information materials in the languages most often encountered in the clinician's practice setting.

References:

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