Contraception - Conclusions

In working with a woman to avoid unintended pregnancies,
a clinician should develop an active partnership
to help her analyze options, select methods, and monitor
outcomes. The clinician must recognize the “best”
method may or may not be the most statistically efficacious,
but one congruent with her risk status, health
beliefs, values, tolerance of adverse effects, lifestyle,
access and willingness/ability to adhere to the regimen.

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Contraception - Medical abortion

Nearly 2% of US women have an induced abortion
yearly73 for a variety of reasons.74 Mifepirostone and
misoprostol have been used as a medical alternative to
surgical abortion methods. The regimens,75,76,77 their
efficacy78 and risks have been described.

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Contraception - Maximizing patient access to contraception

Many circumstances affect a woman’s access to contraception. Clinicians can help women solve many of these difficulties prospectively. Several means exist by which clinicians can expedite access to contraceptives; a breast and pelvic examination and screening for cervical cancer and sexually transmitted infections are not necessary prior to instituting contraception. A medical history and blood pressure check are all that are needed before hormonal contraceptives are prescribed (the medical history can be taken by phone and the blood pressure check by the pharmacist). Although contraceptive visits are frequently used for such evaluations, clinicians should not delay prescribing contraception until these can be accomplished.66,67 The Quick Start method has been outlined to facilitate the use of hormonal contraception.68,69,70,71,72 Many women have some health benefits available to them through insurance. In 2002, in the US, the EEOC ruled that an employer’s exclusion of contraceptives from its health insurance plans constituted sexual discrimination in violation of Title VII of the Civil Rights Act of 1964. It further required employers to cover prescription contraception to the same extent that other drugs, devices and preventive care were covered under the employee’s health care plan. Nonetheless, health plans, including state run Medicaid formularies, may offer only a subset of contraceptive products, or “generics” only. Differential co-pays may be required to access certain methods. Often longer acting methods, such as an IUD, may be less expensive over the length of time used, however they may also be associated with higher “up front costs.” Generic OCPs are nearly always as efficacious as brand-name products and have a fairly equivalent safety profile. Pharmacies also control access to at least some extent with some pharmacists either not stocking or refusing to fill prescriptions for EC for example.

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Contraception - Overweight and obesity

With the overweight and obesity “epidemic” in women of reproductive ages, there are three major issues related to contraception: 1. do contraceptive methods increase weight or weight gain; 2. is contraceptive efficacy impaired in obese women; and 3. should hormonal doses be increased to maximize contraceptive efficacy in overweight women. Although a common concern and even complaint of many women, studies are inconsistent on the impact of contraception on weight gain. The prevalence of weight and oversight increases “over time.” Contraceptive studies monitor women longitudinally. So it is difficult to separate the impact of contraception from “time” itself on weight gain. There is limited evidence to support a causal association among hormonal methods. Users and non-users of contraception all tend to experience weight gain with time. Although there have been some reports of diminished efficacy with some hormonal methods with overweight and obese women, most methods are successful “enough” with more than 95% demonstrated efficacy. Because obesity itself increases the risk of venous thromboembolism there is no justification to compound this risk by increasing the contraceptive “dose” for overweight or obese women. Significantly overweight and obese women may experience greater pregnancy-associated risks.

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Contraception - Women with premenstural dysphoric disorder (PMDD)

Approximately 3–5% of women meet the diagnostic criteria forPMDD. Recent studies of oral contraceptives containing ethinyl estradiol and drospirenone, a progestin with antimineralocorticoid and antiandrogenic activity derived from spironolactone, have demonstrated reduced premenstrual physical and mood symptoms. Yaz® (a COC which contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol) is the only oral contraceptive also FDA approved to treat PMDD. Yaz® is taken for 24 days followed by four days of placebo. This OC may not be appropriate for women with kidney, liver or adrenal disease because it may increase potassium levels. Patients taking drugs that could increase potassium should consult their health care professional before taking Yas® or Yasmin (a COC with 21 days of 3.0 mg of drospirenone and 0.030 mg of ethinyl estradiol ? 7 inert pills), both of which contain drospirenone.35

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Contraception - Women with disabilities

Women with disabilities may require special attention
to reproductive and contraceptive needs. OCPs are
generally safe and effective. Barrier methods may be
difficult to use depending upon the woman’s and/or
her partner’s degree of dexterity and motor function.
Injectable or subdermal progesteronal agents, and
IUDs are efficacious and practical. Sterilization may
be appropriate if children are not desired.

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Contraception - Migraines

Combination hormonal contraceptives may be considered
for non-smoking women <35 years of age
with migraine headaches without focal neurological
signs, who are otherwise healthy.
ACOG recommends clinicians consider the use of
progestin-only, intrauterine, or barrier contraceptives
for women with migraines

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Contraception - Thrombophila

The thrombophilic effect of combination hormonal methods is produced by the estrogen component. Progestin-only contraceptives (injectable progestin, etonogestrel implant, POPs, levonorgestrel releasing IUDs) are more appropriate for women with these conditions, and potentially as well for those with significant coronary vascular disease risk factors. Combination hormonal contraceptives (oral, transdermal or vaginal) are not recommended for women with documented history of unexplained VTE or VTE associated with pregnancy or exogenous estrogen use, unless they are taking anticoagulants. The copper T380A IUD contains no hormones and therefore is an appropriate contraceptive option for these women. Barrier methods are also acceptable, however they have less contraceptive efficacy. At the present time screening for hypercoaguable states is not routinely recommended in low risk women (with a personal history or strong family history of VTE or PE) before initiating a combination hormonal contraceptive. Diabetes Combination hormonal contraception does not adversely affect metabolic control or increase vascular disease or CVD risk in women with type 1 or type 2 diabetes mellitus without vascular disease. In diabetic women with vascular involvement, combination hormonal contraceptive methods are contraindicated. ACOG recommends combination hormonal contraceptives should be limited to non-smoking otherwise healthy women younger than age 35 years with no evidence of hypertension, nephropathy or retinopathy. For women with diabetes without vascular disease or hypertension, the use of copper IUDs, levonorgestrel IUDs, or progestin-only contraceptive methods is not contraindicated. For women with diabetes with vascular disease or hypertension, the use of copper IUDs or progestinonly contraceptive methods is acceptable. DMPA has been associated with increased fasting blood sugar levels in women with well-controlled diabetes. However the clinical significance of this is uncertain. Combination hormonal contraceptive use does not precipitate type 2 diabetes even in women with a history of gestational diabetes.

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Contraception - Perimenopausal women

Many non-smoking healthy women can continue to use OCPs safely past 35 years of age. The hormone content of OCPs may alleviate some menopausal signs and symptoms, help maintain bone integrity, and reduce risks of ovarian and endometrial cancer. On the other hand age and obesity (which is frequently increased in prevalence with aging) are risk factors for cardiovascular disease. VTE increases with age and the risk of VTE attributable to combination OC use increases substantially for women 40 years. Although data on the impact of OC use by women in their 40s and 50s on breast cancer risk is limited, information on the effect of menopausal combined hormone therapy on breast cancer risk should make clinicians cautious and individualize OC use based on risk, patient preferences and review of alternatives. The use of serum FSH in deciding whether a woman is menopausal can be expensive and misleading. Most experts would recommend against using the test to determine whether a woman in her late 40s and early 50s remains “fertile.” If a woman is otherwise healthy and desires combination hormonal contraception after discussion of risks and benefits she may remain on these until 50 to 55 years of age. The use of OCPs in women over 40 years of age has been shown to reduce the risk of hip fracture by 44% and strengthen bone density. Subdermal implants and IUDs may be especially good choices as they confer contraceptive efficacy for 3–7 years after which time the reproductive capacity may diminish. Because fertility declines in the late 40s and early 50s, barrier methods may be relatively more effective.

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Contraception - Chronic hypertension

Oral contraceptives are associated with increased blood pressure even when women use newer products containing dosages of 30 mg of ethinyl estradiol and 150 mg of progestin. DMPA progestin-only pills and IUD use does not appear to increase baseline blood pressure. In deciding whether or not to use combination hormonal contraceptives in women with hypertension, risk of adverse events should be balanced against the known adverse pregnancy outcomes associated with hypertension. Healthy non-smoking women with well-controlled hypertension, no evidence of end organ damage and who are <35 years may be appropriate candidates for a trial of combination contraceptives. If blood pressure remains well controlled several months after contraceptive initiation, and is closely followed up, its use can be continued. Although data are non-existent or inconclusive, it would probably be prudent to consider other combination hormonal contraceptive products (transdermal, vaginal ring) in the same manner as oral hormonal contraceptives. For hypertensive women, progestin-only contraceptives, such as DMPA, POPs, or the levonorgestrel intrauterine system, or copper IUD are appropriate options.

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Contraception - Postpartum

Two-thirds of couples resume sexual relations within the first postpartum month; 90% within the second month. Because ovulation may occur within 3–4 weeks and before the first menses, contraception should be initiated either immediately postpartum or within the first few weeks. Non-breast-feeding women Although there are theoretical concerns regarding postpartum hypercoaguability, there are no definitive clinical data that justify withholding combined contraceptives until four weeks postpartum although this is the recommendation indicated in product labeling. Progestin-only oral contraceptives and DMPA do not contain estrogen, and these methods may be safely initiated immediately postpartum. ACOG recommends DMPA and progestin-only pills be initiated at six weeks postpartum in lactating women and immediately postpartum in non-lactating women if desired. IUDs are less likely to be expelled if inserted immediately following the delivery of the placenta. If not inserted immediately they should be inserted at 6–8 weeks postpartum. Breast-feeding women60,61,62,63 Lactation provides an excellent and reliable contraceptive method for up to six months, with a failure rate of 0.5 to 1.5% for women who exclusively breast feed at least every four hours and experience an absence of menstrual bleeding. Pumping is not an effective substitute for suckling. Another contraceptive method should be initiated if any supplemental feedings are given to the infant, if the feeding frequency decreases, or when the baby reaches six months of age. Spermicides, condoms, and barrier methods are acceptable choices, although diaphragms should be fitted or refitted at approximately six weeks postpartum. A new size of FemCap may need to be prescribed. Fertility awareness methods may require closer scrutiny of physiological parameters. The basal body temperature may not be reliable in the setting of the normal sleep disruption of the newborn period. Progestin methods (Implanon, progestin-releasing IUS, DMPA (104 mg or 150 mg), and progestin-only pills) are recommended after 4–6 weeks postpartum, based largely upon theoretical concerns and animal studies. The World Health Organization recommends that COCs should be avoided in lactating women within the first six weeks postpartum and used with caution between six weeks and six months. Although the estrogen that is transmitted in breast milk has not been shown to be detrimental to the infant, it has been associated with decreased milk supply in some studies. Some lactating women may not be able to compensate with greater milk production. There are essentially no conclusive data in human mothers as to the clinically significant impact of either progestin compounds or combination contraceptives in breast milk on infants. ACOG on the other hand references studies that state the use of hormonal contraception in nourished breastfeeding women does not appear to compromise infant growth or development nor impair lactation. They advise COCs can be used once milk flow is well established. POPs and DMPA do not impair lactation and can be used “immediately.”  Although small amounts of progestin are passed into the breast milk, no adverse infant effects have been documented. Product labeling for progestinonly pills recommends fully breastfeeding women begin tablets six weeks postpartum and partially breastfeeding women begin at three weeks. Use of DMPA immediately post partum does not appear to adversely affect lactation or infant development. ACOG recommends DMPA and progestin-only pills, be used at 6 weeks postpartum in lactating women and immediately postpartum in non-lactating women if desired. Postpartum sterilization, if chosen, should be performed after the infant’s first successful feed to minimize any impact of a delayed first feed on lactation; the mother should be allowed to nurse again in the recovery room. Alternatively, it can be performed at six weeks postpartum. Cigarette smokers Clinicians should prescribe combination hormonal contraceptive methods only cautiously, if at all, to women over the age of 35 years of age who smoke. Barrier methods, injectable progestin, subdermal implants or IUDs are preferred.

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Contraception - Special populations

Adolescents57,58 Abstinence59 Increased abstinence accounted for one-quarter of the drop in the US teen pregnancy rate observed between 1988 and 1995. This decline was caused by lower pregnancy rates among sexually experienced women aged 15–19 years, and not because of a rise in abortions. Abstinence, if a method chosen by the adolescent, should be actively supported and accompanied by specific peer negotiating strategies. Abstinence programs may help adolescents to postpone first intercourse. It may also be a valid method for teens who have been sexually active in the past, but now choose to defer further activity; it can be combined with other methods. EC Counseling regarding the availability of EC may provide a back-up method should abstinence not always succeed. Hormonal therapy OCPs are excellent choices because teens may benefit from non-contraceptive effects such as more regular periods, less dysmenorrhea, and improved acne. The contraceptive patch and Implanon may also be well tolerated. IUDs are generally avoided though data on future fertility in nulliparous women are conflicting. Injectable DMPA may adversely affect bone density and if weight gain occurs this symptom may be less well tolerated among adolescents. If used by adolescents it should be confined to less than two years unless there is convincing evidence that no other method is acceptable. Condoms should be encouraged to enhance whatever contraception the woman chooses as they provides additional contraceptive benefit and some protection from STIs. Information on EC should be offered and a prescription provided if a “back-up” method is desired. EC is available without a prescription only to those over 18 years of age so the younger adolescent benefits from a prescription on hand. The advantages and disadvantages of other over the counter products such as spermicides and the sponge should be addressed in case the woman decides on sexual activity before the next office visit. Abuse Ten percent of young women report that their first intercourse was either “not voluntary” or “rape.” Because coerced sex in this age group is prevalent, clinicians should be vigilant for signs and symptoms of potential abuse.

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Contraception - Male sterilization

Male sterilization is the most cost-effective contraceptive
method, with a failure rate of 0.1 to 4%. Compared
with tubal ligation, it is less expensive, results in
fewer complications and surgical risks, necessitates a
briefer recovery time with less time away from work,
and poses no long-term health risk.
One-half to two-thirds of men will develop sperm
antibodies, but their significance is at the present
time, unknown.
Reversibility though theoretically possible is difficult
and entails additional expense and risk. Male
sterilization therefore should be assumed to be a
permanent method. Success of reversal is related to
the length of time from the original procedure. The
overall success rate is 16 to 79%.

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Contraception - Sterilization Female sterilization

Female sterilization has the advantage of being a single decision which is best thought of as a “permanent decision.” The most common procedures are tubal ligation and Essure® tubal occlusion. In terms of the tubal ligation method, anesthesia, sepsis and hemorrhage can cause mortality, but at a very low rate of 1 to 2 per 70,000. The Essure® tubal occlusion procedure was approved in 2002 and involves placing titanium-dacron coils (micro inserts) into the Fallopian tubes during hysteroscopy. This method involves no surgery and no general anesthesia. Over the course of 3 months, the micro inserts cause tissue to form and block the Fallopian tubes (http://www.essuremd. com/). As many as 6 to 22% of women report subsequent “regret” about their sterilization decision, although only 1% elect to reverse the procedure.52,53 The likelihood of regret is increased in women who have been provided with inadequate counseling, women younger than age 30 years, women who have had postpartum procedures, and women who have experienced a change in their marital status or relationships. Sterilization should be considered a permanent non-reversible option. Although it may be technically possible to reverse some sterilization methods, it is expensive, requires major surgery, and medical insurance does not typically reimburse this expense; success is not guaranteed. The success rate for a subsequent pregnancy is 43 to 86% and assisted reproductive technologies are frequently required. Women seeking this method should be counseled about the availability of other methods, such as OCPs, injectables and IUDs that are effective if used consistently, and more easily reversible. The failure rate for tubal ligation though low, is greater than was once appreciated.54 An average of 18.5 out of 700 women will become pregnant within the seven-year period following sterilization. Onethird of the pregnancies that occur are ectopic. The highest risk of pregnancy is among young women sterilized with bipolar coagulation (54.3/700) or by clip occlusion (52.1/700). Postpartum tubal ligations are less effective than ligations performed at other “interval” periods. The clinician should have a low index of suspicion in ordering a pregnancy test in the evaluation of an individual with relevant symptoms or signs. A pregnant patient with a previous tubal ligation should be assumed to have an ectopic pregnancy unless proven otherwise. Complications Mortality: 1 to 2 deaths/70,000 women compared to a maternal mortality rate of 12.1/70,000 live births. Morbidity Excessive bleeding or hemorrhage, infection, anesthesia-related complications, trauma to abdominal organs, future risk of ectopic pregnancy complications. Sterilization does not cause of lack of libido, loss of femininity, or weight gain. Three primary methods are used: tubal ligation, mechanical occlusion of the Fallopian tubes, and electrocoagulation (the most common and simplest to perform). Mechanical occlusion techniques include clips, rings, or microinserts. Microinserts are relatively new, approved by the FDA in 2002 and inserted transcervically by hysteroscopic visualization. Patients must undergo a hysterosalpingogram three months after surgery and use back-up contraception until occlusion has been confirmed.55 Partner/spousal permission is not required but discussing the decision with the partner may improve the quality of the decision making. Federally funded sterilizations may not be performed on anyone under 21 years of age or incapable of informed consent. There is a 30-day waiting period which extends from the signing of the consent form to the time the procedure is performed.

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Contraception - Vaginal ring

Introduced in the USA in 2001, the vaginal contraceptive
ring (NuvaRing®) is a flexible single-size
(approximately 2 inches in diameter) ring that
releases 5 mg of ethinyl estradiol and 120 mg of etonogestrel
daily.
It is worn continuously for three weeks, and then
removed for one week. The ring can also be removed
for up to three hours at a time if desired. The majority
of women in a clinical study considered insertion and
removal of the vaginal ring to be easy. The failure rate
from the study was 0.65%.

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Contraception - Intrauterine devices (IUDs)

IUDs are the most cost-effective efficacious methods of contraception if used for at least two years.44 IUDs are the most widely used reversible contraceptive worldwide used by 12% of women. However, in the USA, fewer than 2% of women use IUDs, even though user satisfaction is greater than with any other contraceptive method. The two IUDs currently available in the USA, the copper-releasing ParaGard T 380A intrauterine contraceptive and levonorgestrel-releasing intrauterine system (IUS), are both T-shaped and have monofilament tails. They can be inserted at any time of the menstrual cycle. The copper variety may be used as an “emergency contraceptive method” if inserted within five days of unprotected intercourse. If used postpartum, it should be inserted within 7 minutes of delivery of the placenta or at 6–8 weeks. The copper IUD is effective for seven years. Its failure rate is 0.7% in the first year of use. The copper IUD impairs sperm motility and viability, disrupts oocyte division and the formation of fertilizable ova. Changes also occur in the endometrium that could interfere with the implantation of a fertilized ovum. Its primary disadvantage is an average 55% increase in monthly blood loss and dysmenorrhea.45 Both IUDs have efficacy rates comparable to sterilization. The levonorgestrel-releasing IUD is the most effective of the currently available IUDs. Its first-year failure rate is 0.1%. Progesterone-releasing IUDs thicken cervical mucus, impeding the movement of sperm. They inhibit sperm capacitation, survival and motility, suppress ovulation (in some women), thin and suppress the endometrium, and stimulate an inflammatory reaction that may impede sperm function and prevent implantation. It may affect tubal mobility and implantation. In addition to contraception, it can be used to treat menorrhagia, dysmenorrhea, and endometriosis. It can also be used for supplemental progesterone in women who take estrogen for hormone replacement therapy (HRT). Side effects While IUDs do not increase the risk of pelvic inflammatory disease (PID), this can occur within the first 20 days following insertion. The incidence of PID decreases from 7/700 within the first 20 days to 1/700 after 21 days. IUD users may acquire PID, either during the insertion process and/or from sexual activity. To decrease this risk, IUDs are generally not indicated if either the woman or her partner have multiple sexual partners and are therefore more likely to develop sexually related PID. The routine use of antibiotics administered orally one hour before insertion is not recommended.46,47 Even though antibiotic prophylaxis against subacute bacterial endocarditis is appropriate for women with valvular heart disease, prophylactic antibiotics are unnecessary for women with mitral valve prolapse. Actinomyces-like organisms are common in the genital tract. Symptomatic IUD users with positive actinomyces findings on a Pap smear should be treated with appropriate antibiotics and their IUD removed. Asymptomatic IUD users do not require IUD removal or antibiotic therapy. Complications also include uterine perforation and expulsion. Uterine perforation during insertion is rare. The expulsion rate is 2–7% within the first year. There is a higher risk of expulsion in nulliparous women and in women with severe dysmenorrhea or excessive blood flow. If a woman experiences expulsion, she has a 30% risk of having a second IUD expelled. Contrary to a widespread misperception, copper IUDs actually reduce the risk of ectopic pregnancy. In fact, the rate of ectopic pregnancy is 90% lower than in women who use no form of birth control. If a woman becomes pregnant while using the IUD, there is a 5% risk of an ectopic pregnancy. Any woman who conceives while using any method of contraception should be assumed to have an ectopic pregnancy until proven otherwise. A woman who conceives using the subdermal implant has a 17% chance of an ectopic pregnancy. A woman using a progestin-only OCP and who conceives has a 7% chance of an ectopic pregnancy, and a woman with tubal sterilization who conceives has a 33% chance (Figure 7.1).48 An IUD user who has an intrauterine pregnancy has a 50% risk of a spontaneous abortion. This risk can be reduced by the early removal of the IUD, if necessary under ultrasound guidance. Contraindications Nulliparity is not a contraindication to IUD use, although any potential IUD user should be counseled about the potential risk of PID and subsequent sterility. Parous women are not reported to have demonstrable changes in future fertility compared to users of other contraceptive methods; there are conflicting data in nulliparous women.49 Contraindications to IUD use are listed in Table 7.10. The levonorgestrel-releasing IUD can be used to treat menorrhagia and anemia and as an alternative to hysterectomy in women with bleeding.50 Follow-up Patients who do not practice safe sex are probably not good candidates for IUDs. If PID develops, the infection should be treated and the IUD should be removed if symptoms fail to improve within 72 hours after treatment begins. If a sexually transmitted infection (STI) is diagnosed, the infection should be treated but IUD removal is not necessary. If the patient cannot feel the IUD string and it cannot be visualized, pregnancy should be excluded. The clinician can probe for string presence in the cervical canal or a pelvic ultrasound can be used to evaluate whether the IUD is still present and within the uterine cavity.

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Contraception - Subdermal implants

The Norplant system was a six-rod progestin implant that was implanted in the skin of the arm and released 50 to 80 mg levonorgesterel the first year and 30 and 35 mg per year for each of the following four years. In 2000, the manufacturer issued an advisory that the contraceptive efficacy of certain lots of the implants could not be guaranteed, and it was withdrawn. Implanon™ was approved in 2006. It is a single rod progestin subdermal implant that is about the size of a match stick. It continually releases a steady dose of progestin (etonogestrel) for up to three years. Its effect is quickly reversible. A woman’s fertility returns within 24–72 hours of removal. Its primary mechanism of action is to inhibit ovulation although it also increases the viscosity of cervical mucus. It can be used for lactating women after the fourth postpartum week.43 It is placed in the groove between the biceps and triceps muscles and can only be inserted and removed by clinicians who complete a formal training program. Efficacy Six pregnancies have been reported in 20,648 cycles. Side effects Side effects include irregular menses and headache. Bleeding irregularities usually decrease over the first six to twelve months and after that time most women experience amenorrhea. At the end of the first year the mean cumulative weight gain was 2.8 pounds and by the end of the second year 3.7 pounds. Less common side effects are acne, change in appetite, change in libido, ovarian cysts, discoloration or scarring of the skin over the implant, dizziness, hair loss, headache, nausea, nervousness, pain at the insertion site or sore breasts. Contraindications Contraindications include active liver disease, active thrombophlebitis, known or suspected breast cancer, undiagnosed abnormal gynecological bleeding, pregnancy, or hypersensitivity to the drug. Some medications may make Implanon™ less effective. These include barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and modafinil as well as possibly herbal remedies such as St. John’s Wort. Interested clinicians should register at the website http://www.implanon-usa.com/hcp/index.asp?C=571 37391742296759259&OrgDom=www.implanonusa.com or http://www.implanon-usa.com/hcp/index.asp?svar qvp2=0 for information on training.

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Contraception - Injectable progestin

Approximately 1% of US women elect to use injectable depot medroxyprogesterone acetate (DMPA). Intramuscular DMPA (150 mg) provides effective contraception for 12 weeks. A new, lower DMPA formulation at a 30% decreased dose (104 mg) administered subcutaneously is currently available. It has been demonstrated to be equally efficacious as the higher does. Although as yet no controlled trial has compared it directly to the 150 mg dose, anecdotally the side effects are similar.42 There is an increased risk of pregnancy if the injection is delayed to 14 weeks and if given beyond 12 weeks. In these cases, a back-up contraceptive should be used for two to four weeks. The lower dose, subcutaneous 104 mg medroxyprogesterone acetate injectable, FDA approved in 2004, is available as prefilled syringes that can be administerd into the thigh or abdomen every 12–14 weeks. It can be given by the clinician or the woman herself, much as individuals give themselves insulin. The dose does not need to be adjusted based on body weight. Fertility usually returns in four to nine months, but may take as long as 18 months. Duration of use is not related to the length of time before fertility returns. This is particularly effective if temporary excellent contraception is required as during the use of isotretinoin or other medicines, or while waiting for confirmation of vasectomy success. Side effects Menstrual disturbances are common. Bleeding can be treated with NSAIDs, combined combination oral contraceptives, or 7 to 13 days of oral estrogen. Amenorrhea is common; over half of women develop amenorrhea within the first year, and three-quarters after the second year. Weight gain has been an issue for many women. The average weight gain is 2 kg (5 lbs) during the first year of use and 5? kg (11? lbs) during the second year. Overweight and obese women have lower efficacy rates. Other side effects include bloating, decreased libido, dizziness, mood changes, acne, palpitations, depression, breast tenderness, and headache. Total cholesterol and LDL may increase while HDL decreases. Bone recovery Bone mineral density may be reduced in women younger than age 20 years. Duration of use also plays a role, and women who use this method for more than five years are at particular risk. In 2004, the FDA added a “black box” warning to the labeling indicating that women who use Depo-Provera contraceptive injection may lose significant bone mineral density; bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown whether use of Depo-Provera contraceptive injection during adolescence will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. Depo-Provera contraceptive injection should be used as a long-term birth control method (e.g. longer than two years) if other methods are “inadequate.” There is a relatively high rate of discontinuation from this method, perhaps because it is associated with irregular bleeding, weight gain, and increased headaches. Alternatives The availability of alternative contraceptive strategies should be discussed at each visit. Adolescents, in particular, may simply not return for a subsequent injection and yet fail to substitute an effective contraceptive.

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Contraception - Contraceptive patch

The combination contraceptive patch (OrthoEvra®)
was introduced in 2002 and offers ease of use with
weekly replacement. It combines continuous systemic
doses of norelgestromin and ethinyl estradiol. The
patch is applied weekly three of four weeks; the fourth
week no patch needs to be applied. Risks, benefits and
potential drug interactions in general are similar to
those for oral contraceptives. The patch is associated
with 60% higher total exposure to ethinyl estradiol
than with the 35 mg pill, but peak estrogen levels are
lower. The significance of these data is currently
unknown. With typical use, its efficacy is reported to
be greater than that of an oral contraceptive and it
is easily reversible.38 In November 2005 the FDA
added information to the OrthoEvra label about the
increased exposure to estrogen in women who use
the patch compared with oral contraceptives containing
norgestimate and 35 mg ethinyl estradiol. In
September 2006 the FDA announced an update to
the OrthoEvra product label stating that users may
be at increased risk of thromboembolism (VTE)
when compared with OCP users and advising that
women with concerns or risk factors to talk with their
health care provider about using OrthoEvra versus
other contraceptive options. The FDA warning was
based on analysis of two studies. One study found the
risk of VTE doubled, another found no increased
risk in users of the patch. Women immobilized due
to surgery or injury should discontinue the patch
because of the associated risks for venous thromboembolic
events.39,40
The patch may be less effective in women
weighing more than 198 pounds. One study reported
less bleeding in women who applied the patch for
more weeks before the patch-free week.41

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Contraception - Oral contraceptive pills (OCPs)

OCPs are hormonal methods of birth control. There
are two general varieties: combination oral contraceptive
pills (COCs) consist of estrogen (usually 20–50
mg ethinylestradiol) and progesterone (e.g. levonorgestrel,
norethindrone, desogestrel, norgestimate); the
progestin-only pills (POPs) contain only progesterone.
By comparison, the estrogen dose in COCs
available 30 years ago was at a dose of 50 to 80 mg
and even higher. COCs are further classified as monophasic (fixed
dose of estrogen and fixed dose of progestin), biphasic
(fixed dose of estrogen with two different progesterone
doses), or triphasic (fixed concentration of
estrogen and three increasing concentrations of progesterone).
One COC varies the dose of estrogen
throughout the cycle with a single fixed dose of progesterone.
There are no documented clinically significant
differences among these combination pills.
POPs or “mini pills” contain one of two different
kinds of progesterone. They are used by fewer than
1% of OCP users and are less effective than COCs.
Their efficacy is very sensitive to the timing of the
doses and ideally they should be taken at the same
time of day each day. A back-up contraceptive should
be instituted if the dose is delayed by more than
3 hours. Menses may be irregular or absent.
Newer COCs have been developed that offer additional
options in dosing. “Very low dose estrogen”
pills contain less than 20 mg. Although very low dose
estrogen pills minimize the risk of venous thromboembolism
compared with older estrogen doses
greater than 50 mg, they have not been proven to be
safer than OCPs with an intermediate estrogen dose
of 30 to 50 mg. They are associated with more breakthrough
bleeding, which may be problematic for
patients.
Most COCs combine 21 days of “active pill” with
7 days of placebo during which withdrawal bleeding
occurs.
More recent COCs have been introduced that
reduce or even eliminate the 7 day placebo interval.
Two 28 day products, Yaz® (3 mg of drospirenone
and 20 mcg ethinyl estradiol) and Loestein®24 FE
(1 mg norethindrone acetate and 20 mcg ethinyl
estradiol) provide active hormone for 24 instead of
21 days followed by four (not seven) inert pills.
There are also currently extended pill regimens,
which reduce the number of withdrawal bleeding
episodes per year. Seasonale® (levonorgestrel 150
mg/ethinyl estradiol 30 mg), has 84 days of active pills,
followed by 7 inert pills for a hormone-free week.
Seasonique™ (84 tablets of 150 mg levonorgestre/
estradiol 30 mg and 7 tablets containing 10 mg ethinyl
estradiol) completely eliminates the hormone free
interval by using seven days of low-dose estrogen
(10 mg ethinyl estradiol) during what otherwise would
be the pill-free interval. Breakthrough bleeding and
spotting are more common but decline with time. The
total dose of estrogen for women with these products
is greater than for the traditional 28 day pills, but the
clinical significance of this is unknown.31
OCPs using new progestins, such as norgestimate
and desogestrel, are referred to as third-generation
progestins. They are associated with fewer androgenic
side effects such as acne and hair loss, they do not
affect weight or blood pressure, and are associated
with negligible changes in blood glucose, plasma insulin
or lipids. A few years ago some studies linked them
to an increased risk of thromboembolism; however,
the evidence is inconclusive.
OCPs offer many non-contraceptive benefits.10
The newer progestin-containing OCPs increase high
density lipoprotein cholesterol (HDL-C). Perimenopausal
users of OCPs with 50 mg of estrogen demonstrate
increased bone density and may reduce their
risk of hip fracture by 44%. Triphasic OCPs combining
norgestimate are as efficacious as topical tretinoin,
benzoyl peroxide, and topical or systemic
antibiotics for the treatment of moderate acne vulgaris.
Table 7.8 lists other conditions ameliorated or
lessened by the use of oral contraceptives.
OCPs protect against certain reproductive cancers
of the endometrium and ovary. The risk of ovarian
cancer is decreased by 40% among OCP users; this
benefit persists for up to 20 years following discontinuation
of the pill. Women who use OCPs for ten or
more years reduce the risk of ovarian cancer by 80%.
BRCA-positive women experience similar reductions
in risk. The risk of endometrial cancer is decreased by 40% in women who use OCPs for at least two years,
and 60% if OCPs are used for at least four years.
The link between OCP use and breast cancer is
less conclusive. A 1996 collaborative analysis of over
53,000 women with breast cancer enrolled in 53 studies
from 25 countries concluded that “ever users” of
OCPs had a 1.07 relative risk of breast cancer unrelated
to dose or duration of use. However, OCP users
had a lower risk of metastatic disease (R ¼ 0.88
compared with non-users).32
For most women, pregnancy and/or abortion are
associated with a greater risk of mortality and morbidity
than oral contraceptives. In attempting to assist
the individual woman and her clinician in decisionmaking,
the World Health Organization has replaced
a single list of “contraindications” with four categories
of increasing “precautions” for women considering
OCPs.33 Category 1 consists of conditions for which no
restrictions to pill use are necessary. Category 2 contains
medical conditions for which the advantages
of OCPs outweigh known risks. Category 3 includes
conditions for which the clinician should exercise
caution but not necessarily refrain from prescribing.
Only category 4 conditions are felt to be so significantly
linked to OCP use that WHO recommends
patients with these conditions should refrain from
using OCPs (Table 7.9).
Thromboembolism, found in category 4, is believed
to be related less to the dose of hormone than
to the duration of use; there is a decreased risk over
time.34
Some medical conditions may worsen with the use
of OCPs. If this occurs, an oral contraceptive with a
lower estrogen dose or progestin-only oral contraceptive
can be substituted. Women with well-controlled
diabetes mellitus, hypertension, and hypertriglyceridemia
(triglycerides <750 mg/dL) should be followed
closely but most will do well on OCPs. OCPs are
generally contraindicated in women over 35 years of
age who smoke cigarettes. Newer OCPs with low doses
of estrogen or progestin-only pills are associated with
less risk of heart disease. Women who have migraines
may have risks associated with OCPs. If a woman’s
migraines are controlled, she may try a lower dose
estrogen COC or POP. If headaches worsen, OCPs
should be discontinued and another method used.
Side effects
Most women will experience breakthrough bleeding
(BTB) within the first three months of OCP use. If
pregnancy has been excluded, BTB is not necessarily
a reason to change pills. Breakthrough bleeding is
more common with POPs. It may be managed
with NSAIDs, a change to COCs, a second- or thirdgeneration
COC, or 7–13 days of oral estrogen
although there are no randomized trials which support
the efficacy of any of these regimens over another.
If the patient develops hair thinning or acne,
a product containing a low androgenic progestin such
as desogestrel or norgestimate can be considered.
Most women using OCPs will have a blood pressure
rise of less than 5 mmHg, which generally resolves
within three months of discontinuing the pill. Mood
changes and fatigue are usually related to the progestin
component. A change to a different progestin or a
decrease in dose may ameliorate symptoms.35 Some
women prefer amenorrhea to continued end-of-cycle
bleeding. This will usually be accomplished by continuing
directly with the active pills from the next
pack once a pack is completed, and neither “stopping
the pills for seven pill free days,” nor using the “placebo”
pills. Women with uncomfortable premenstrual
symptoms that occur during the pill free or placebo
days may benefit from continuing directly with the
first active pill from the next pill pack.
Missing pills
If a woman misses one pill she should take two pills
the next day and continue with the rest of the pack as
usual. If she misses two pills in the first two weeks of
the cycle, she should take two pills each day for two
days and then complete the pack as usual using a
back-up method of contraception. If she misses two
pills in the third week or misses additional pills, the
pack should be discarded and a new pack used. She
should use a back-up method of contraception for at
least seven days.36
Teratogenic effects
Teratogenic effects have probably been overstated in
the past. If a woman inadvertently becomes pregnant
while using OCPs, the pills should be discontinued
but therapeutic abortion is not necessary.
Vacations and subsequent fertility
Pill free periods are unnecessary. When she wishes
to conceive, the woman needs only to discontinue
the pill. Over 50% of women will become pregnant
in three months and 80% in one year. Folic acid
supplementation is a desirable preconception addition because OCPs may deplete folic acid stores. The
woman does not need to wait three months after
discontinuing the pill before conception.
Medications
OCPs may affect, or be affected by, the concurrent use
of other medications, especially seizure medication
and some antibiotics.
Pathophysiology
Although the primary mechanism of OCPs is to
inhibit ovulation, secondary mechanisms also occur,
especially with the low dose pills, progestin-only pills,
and inconsistent use of OCPs. These include “postfertilization”
effects. Larimore and Stanford suggest
that the evidence is compelling enough that patients
should be fully informed about the mechanisms of
action so that individuals with reservations involving
postfertilization mechanisms have the opportunity to
make a truly informed decision.37
Starting OCPs
A complete physical examination, Pap smear and
pelvic examination do not need to be performed prior
to initiating OCPs.
A quick-start method has been described, and has
the advantage of simplicity.

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