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Página 1 De 22 Página 1 de 22 ©2006 UpToDate ® Official reprint from UpToDate® www.uptodate.com Overview of the use of estrogen-progestin contraceptives Kathryn A Martin, MD Robert L Barbieri, MD UpToDate performs a continuous review of over 350 journals and other resources. Updates are added as important new information is published. The literature review for version 14.2 is current through April 2006; this topic was last changed on April 21, 2006. The next version of UpToDate (14.3) will be released in October 2006. INTRODUCTION — Oral contraceptives (OCs) are a reliable form of contraception and have noncontraceptive benefits as well. Furthermore, the decrease in both estrogen and progestin content in the last decade (so-called second generation OCs) has led to a reduction in both side effects and cardiovascular complications (show table 1) [1]. As a result, these preparations are a reasonable contraceptive option for many women. While the Food and Drug Administration had previously set upper age limits for OC use as 35 years for smokers and 40 years for nonsmokers, all references to age limits were removed in 1989 for healthy, nonsmoking women. Thus, OCs can be given until menopause in such women. This topic will review the general principles of the use of oral contraceptives, including pharmacology, mechanism of actions, indications, contraindications, efficacy, and the different preparations that are available. The side effects that may be associated with OCs and the topic of contraception in general are discussed separately. (See "Risks and side effects associated with estrogen- progestin contraceptives" and see "Overview of contraception"). PHARMACOLOGY — The discovery in 1938 that addition of an ethinyl group to estradiol resulted in both an orally active estrogen compound and a dramatic increase in estrogenic potency was a major advance in steroid biochemistry. This compound, known as ethinyl estradiol, is the estrogen in virtually all currently used OCs. Soon thereafter, ethinyl substitution of testosterone also was found to result in an orally active compound (ethisterone). Removal of the carbon at the C-19 position of ethisterone changed it from an androgen to a progestin. This finding resulted in the development of a class of progestins referred to as 19-nortestosterone derivatives. Included in this class are commonly used progestins such as norethindrone, norethindrone acetate, and levonorgestrel. Ethynodiol diacetate, another progestin in this category, also has significant estrogenic activity. All of these testosterone-derived progestins bind to the androgen receptor and have some residual androgenic activity. The adverse metabolic effects of OCs, such as the reduction in serum high- density lipoprotein (HDL) cholesterol concentrations, are the result of the androgenic activity of the progestin. New progestins have been developed with less androgenic activity; however, their safety is uncertain (see "New progestins" below). MECHANISMS OF ACTION — While OCs have several mechanisms of action, the most important for providing contraception is estrogen-induced inhibition of the midcycle surge of gonadotropin secretion, so that ovulation does not occur. (See "The normal menstrual cycle"). Combination OCs are potent in this regard, but progestin-only pills are not. Página 2 de 22 Another potential mechanism of contraceptive action is suppression of gonadotropin secretion during the follicular phase of the cycle, thereby preventing follicular maturation. However, a substantial number of women develop follicles while taking an OC that contains 20 to 35 mcg of ethinyl estradiol [2]. Clinicians often recommend that back-up contraception be used in the first cycle of OC use, due to concern that early follicular development could result in breakthrough ovulation (most package inserts recommend starting the pill on the first Sunday after menses, which could be as late as day seven). In a study of 140 women randomly assigned to start their oral contraceptive (containing 30 ug ethinyl estradiol/day) on day 1, 4, or 7 of menses, follicular development (diameter > 13 mm) was more common with the later start days (10.3, 17.2, and 44.4 percent for days 1, 4, and 7, respectively) [3]. However, rates of ovulation were no different in the three groups (7, 3, and 0 percent, respectively). Thus, back-up contraception might not be necessary in the first month of OC use, but a larger study is needed before changing clinical practice. This observation highlights the importance of preventing the midcycle surge of gonadotropin secretion. Other estrogenic mechanisms of action include suppression of ovarian steroid production, due to suppression of gonadotropin secretion, and a possible decrease in responsiveness of the pituitary to gonadotropin-releasing hormone. Progestin-related mechanisms also may contribute to the contraceptive effect. These include: z Effects on the endometrium, rendering it less suitable for implantation z Alterations in cervical mucus, which becomes less permeable to penetration by sperm z Impairment of normal tubal motility and peristalsis Use in hyperandrogenism — Combination OCs are useful for the treatment of women with hyperandrogenism (most often due to idiopathic hirsutism and polycystic ovary syndrome). Levonorgestrel-containing preparations may aggravate these problems, and should be avoided. These women are best treated with an OC that contains norethindrone, ethynodiol diacetate, or a third-generation progestin (see "New progestins" below). (See "Use of combination estrogen-progestin contraceptives in the treatment of hyperandrogenism and hirsutism"). Among the beneficial effects of an OC in women with hyperandrogenism are: z An increase in serum SHBG concentrations, which results in a decrease in serum free androgen concentrations z Inhibition of gonadotropin secretion, which results in a decrease in ovarian androgen secretion z Inhibition of adrenal androgen secretion The mechanism of the last effect is not well understood. It may be related to an elevation in serum cortisol-binding globulin concentrations, with a subsequent increase in the serum cortisol concentration leading to inhibition of pituitary corticotropin (ACTH) secretion [4]. Use in other disorders — There are many other indications for the use of OCs other than contraception and hyperandrogenism. These include the treatment of dysmenorrhea, menorrhagia, other menstrual cycle disorders such as hypothalamic amenorrhea, and as hormone replacement in women with primary hypogonadism. (See appropriate topic reviews.) OCs have also been used for the treatment of the premenstrual syndrome but their efficacy has not been established in this setting. (See "Treatment of premenstrual syndrome and premenstrual dysphoric disorder"). CONTRAINDICATIONS — There are a number of absolute and relative contraindications to the use of OCs. The absolute contraindications are: z Previous thromboembolic event or stroke z History of an estrogen-dependent tumor Página 3 de 22 z Active liver disease for two theoretical reasons — orally administered steroids are metabolized in the liver, and metabolism would be impaired in a diseased liver; and there may be a slight increase in the risk of mild liver disease in users of high dose OCs [5] z Pregnancy — although inadvertent OC administration during early pregnancy has not generally been associated with an increase in risk of congenital anomalies, a possible exception is congenital urinary tract abnormalities [6] z Undiagnosed abnormal uterine bleeding z Hypertriglyceridemia z Women over age 35 years who smoke heavily (greater than 15 cigarettes per day); OCs can be considered in older women who smoke fewer cigarettes (see "Risks and side effects associated with estrogen-progestin contraceptives", section on Cardiovascular disease.) In addition, the pros and cons of OC use should be carefully weighed in women with poorly controlled hypertension (women with controlled hypertension are reasonable candidates), and women receiving anticonvulsant drug therapy. The World Health Organization recommends that oral contraceptives not be used in women over age 35 with migraines, or in women of any age with migraines with aura (show table 9). Diabetes mellitus is not a contraindication to OC treatment, but some diabetic women need a small increase in insulin dose (show table 2). (See "Risks and side effects associated with estrogen-progestin contraceptives"). Screening requirements — Hormonal contraception can be safely provided after a careful medical history and blood pressure measurement. While breast exams, pap smears, and screening for sexually transmitted diseases are important, most groups, including the American College of Obstetricians, the World Health Organization, and the Royal College of Obstetricians and Gynecologists agree that these procedures are not necessary before a first prescription for OCs [7]. EFFICACY — When taken properly, OCs are a very effective form of contraception. Although the theoretical failure rate is 0.1 percent, the actual failure rate is 2 to 3 percent due primarily to missed pills or failure to resume therapy after the seven-day pill-free interval (show table 3). Missed pills — Missed pills (particularly if the seven-day pill-free interval is extended) is a common cause of contraceptive failure. In general, a hormonally active pill should be taken as soon as possible when a pill has been missed. The World Health Organization recommends that no back-up or emergency contraception is necessary unless three
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