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Chapter 8: Prescription Therapies

CONTRACEPTIVES

Key Points

  1. Despite a decline in fertility, women of older reproductive age who do not wish to conceive should use effective contraception until 1 year after the final menstrual period.
  2. Long-acting reversible contraceptive methods, which include the copper intrauterine device (IUD), the two levonorgestrel intrauterine systems, and the etonogestrel subdermal implant, provide superior contraceptive effectiveness (equivalent to sterilization) and higher continuation rates compared to shorter-acting methods.
  3. Although no contraceptive methods are contraindicated on the basis of age alone (except for the use of oral contraceptives in smokers aged older than 35 years), women of older reproductive age may have medical conditions that increase the risks associated with certain methods, rendering them inappropriate.
  4. Additional benefits of combined estrogen-progestogen contraceptives for perimenopausal women include management of vasomotor symptoms and abnormal uterine bleeding.

Recommendations for Clinical Care

  1. Evidence-based guidelines from the Centers for Disease Control and Prevention represent a valuable resource for clinicians and women of older reproductive age when selecting appropriate contraceptive methods and managing contraceptive issues. (Level II)
  2. Contraceptive methods that contain estrogen should be used with caution in women of older reproductive age who smoke, are obese, or have other risk factors for cardiovascular disease. In most cases, progestogen-only methods and the copper IUD provide effective, safe alternatives. (Level II)
  3. The higher-dose levonorgestrel intrauterine system can be used as a first-line treatment for heavy menstrual bleeding and is an effective reversible alternative to endometrial ablation and hysterectomy. (Level I)
  4. Combination hormonal contraceptives provide important noncontraceptive benefits, including treatment of irregular uterine bleeding, reduction of vasomotor symptoms, decreased risk of ovarian and endometrial cancer, and maintenance of bone mineral density. (Level II)

ESTROGEN THERAPY AND ESTROGEN-PROGESTOGEN THERAPY

Key Points

  1. Treatment of moderate to severe vasomotor symptoms is the primary indication for hormone therapy (HT). The benefits outweigh the risks for most healthy, symptomatic women aged younger than 60 years or within 10 years of the final menstrual period.
  2. Progestogen therapy (progesterone and synthetic progestogens) is an option to treat hot flashes, but it is not as effective as estrogen, and long-term safety data are limited. Its primary use in postmenopausal women is to reduce the risk of endometrial cancer associated with unopposed estrogen therapy (ET).
  3. An increased risk of breast cancer was seen with 3 to 5 years of estrogen-progestogen therapy use in the Women’s Health Initiative, whereas no increased risk of breast cancer was seen with 7 years of ET use, allowing for more flexibility in duration of ET use in women without a uterus.
  4. Both transdermal ET and low-dose oral ET have been associated with a lower risk of venous thromboembolism and stroke compared with standard-dose oral ET in observational studies, but evidence from randomized, controlled trials is lacking.
  5. A combination of the selective estrogen receptor modulator bazedoxifene with conjugated estrogen is approved for the treatment of vasomotor symptoms and prevention of osteoporosis in women with a uterus.
  6. Systemic HT and low-dose vaginal ET are very effective treatments for moderate to severe symptoms of vulvar and vaginal atrophy (vaginal dryness, dyspareunia, and atrophic vaginitis). The estrogen agonist/antagonist ospemifene is a new oral agent approved for this indication.

Recommendations for Clinical Care

  1. The lowest dose of HT should be used for the shortest duration needed to manage menopausal symptoms. Individualization is important in the decision to use HT and should incorporate the woman’s personal risk factors and her quality-of-life priorities in this shared decision. (Level II)
  2. Extended duration of HT use might be appropriate in symptomatic women or for the prevention of osteoporosis, if alternative therapies are not tolerated. A careful assessment of individual benefits and risks is advised in these cases. (Level III)
  3. The use of custom-compounded bioidentical HT is not recommended, given limited product quality control and lack of evidence that it is safe or effective. (Level III)
  4. When ET is considered solely for treatment for moderate to severe symptoms of vulvar and vaginal atrophy, the use of low-dose vaginal ET rather than systemic ET is advised due to its greater safety profile. (Level II)
  5. Women with primary ovarian insufficiency or early menopause without contraindications to HT should consider the use of HT or combined estrogen-progestogen contraceptives until the average age of natural menopause (52 years). Longer duration may be considered for symptomatic women. (Level II)
  6. Hormone therapy should not be prescribed for chronic disease prevention. (Level I)

COMPOUNDED HORMONE THERAPY

Key Points

  1. The term custom-compounded hormone therapy (HT) describes the mixing of hormones by a pharmacy based on a prescription reportedly customized for an individual woman, often based on blood or salivary hormone levels. These HT products typically contain one or more hormones in differing amounts in addition to other ingredients to create a cream, gel, lozenge, tablet, spray, or skin pellet.
  2. Although the term bioidentical hormones is often used to describe custom-compounded HT products as they typically contain only hormones structurally identical to those produced by a woman’s ovaries during the reproductive years, the term was invented by marketers and has no clear scientific meaning.
  3. Use of custom-compounded HT has increased significantly since the initial publication of the Women’s Health Initiative as women seek alternative therapies.
  4. Compounding pharmacies are regulated by state pharmacy boards, with little oversight by FDA.
  5. Compounded hormones are not tested for safety and efficacy as are FDA-approved commercially manufactured HT products.
  6. Compounded hormones do not routinely include the product information sheet required by FDA of commercially manufactured HT products.
  7. Advertising and promotional claims regarding the efficacy and safety of compounded hormones are not validated by medical evidence.
  8. Consumers generally are unaware of the limited control FDA exercises over the marketing and safety monitoring of compounded hormones.

Recommendations for Clinical Care

  1. Prescription of custom-compounded HT is not advised due to lack of quality control and regulatory oversight of these products, with concerns regarding product efficacy and safety. (Level I)
  2. The use of serum or salivary hormone levels is not recommended to assist in the management of HT as these levels are of no value in either selecting initial medication doses or monitoring therapy for menopausal symptoms. (Level II)
  3. Women requesting bioidentical or custom-compounded HT should be encouraged to use FDA-approved HT products that are biochemically identical to the hormones naturally produced by the ovaries during reproductive life (eg, estradiol and progesterone). Approved HT products are available in a wide range of doses, which may be adjusted to meet the individual needs of each woman. (Level II)

ANDROGENS

Key Points

  1. Androgen levels decline in women with aging but do not change across the menopause transition. Androgen levels are significantly lower in women with primary ovarian insufficiency and following bilateral oophorectomy.
  2. There is evidence to support the use of testosterone therapy in carefully selected postmenopausal women with female sexual interest/arousal disorder (previously known as hypoactive sexual desire disorder) and no other identified etiology for their sexual problem.
  3. The long-term risks of androgen therapy in women, including possible effects on the risk of cardiovascular disease or breast cancer, are unknown.
  4. There is no evidence to support the use of dehydroepiandrosterone (DHEA) for the management of female sexual interest/arousal disorder. Research is ongoing regarding the use of vaginal DHEA in postmenopausal women with symptomatic vulvovaginal atrophy and associated decreased libido.
  5. There are currently no androgen-containing prescription products government-approved for the treatment of female sexual interest/arousal disorder in the United States or Canada.

Recommendations for Clinical Care

  1. A trial of testosterone therapy may be considered in carefully selected postmenopausal women with female sexual interest/arousal disorder and no other etiology for their sexual problems. Women must be informed of potential adverse effects and unknown long-term risks. (Level I)
  2. Women using testosterone should be monitored for adverse effects, including facial hair, acne, voice changes, clitoromegaly, and adverse changes in lipids or liver function tests. Blood testosterone levels should be checked intermittently to ensure that levels remain in the normal range for reproductive-aged women. (Level II)
  3. Formulations of testosterone approved for the treatment of men increase the risk of excessive dosing when prescribed for women. (Level II)
  4. There is currently no role for the use of DHEA in the treatment of female sexual disorders. (Level I)

SELECTIVE ESTROGEN RECEPTOR MODULATORS

Key Points

  1. Selective estrogen receptor modulators (SERMs) are compounds that act as estrogen agonists in some tissues and as estrogen antagonists in others. Different SERMs provide different tissue-specific actions, allowing for individualization depending on the medical needs of the postmenopausal women.
  2. SERMs available in the United States and Canada include tamoxifen, approved for prevention and treatment of breast cancer; toremifene, approved for treatment of breast cancer; raloxifene, approved for prevention and treatment of osteoporosis, and prevention of breast cancer; and ospemifene, approved for treatment of dyspareunia due to postmenopausal vaginal atrophy.
  3. The first tissue-selective estrogen complex (TSEC) is a pairing of conjugated estrogens with the SERM bazedoxifene, approved for the treatment of vasomotor symptoms and the prevention of osteoporosis in women with a uterus. Bazedoxifene provides endometrial protection, so a progestogen is not needed.
  4. In addition to its known benefit for prevention and treatment of breast cancer, tamoxifen is an estrogen agonist in bone and reduces bone loss in postmenopausal women at the spine and hip. Adverse effects include an increased risk of uterine cancer, venous thromboembolic events (VTEs), and cataracts.
  5. Raloxifene increases bone mineral density and decreases the risk of osteoporotic vertebral, but not hip or nonvertebral, fractures. Raloxifene also reduces the risk of invasive breast cancer in postmenopausal women at increased breast cancer risk. Raloxifene increases the risk of VTEs but does not increase the risk of uterine cancer.
  6. Ospemifene improves vaginal pH, vaginal maturation index, and dyspareunia due to vulvovaginal atrophy in postmenopausal women. No trials have evaluated ospemifene’s effects on the prevention or treatment of breast cancer or osteoporosis.

Recommendations for Clinical Care

  1. The decision to initiate or continue therapy with a SERM or TSEC should be individualized based on the clinical needs of the postmenopausal woman, her medical history, and the known risks and benefits of each agent. (Level II)
  2. SERMs may be used to prevent breast cancer (tamoxifen, raloxifene), treat breast cancer (tamoxifen, toremifene), prevent and treat osteoporosis (raloxifene), and treat moderate to severe dyspareunia due to vaginal atrophy (ospemifene). (Level I)
  3. The TSEC bazedoxifene combined with conjugated estrogens may be used in women with a uterus to treat moderate to severe vasomotor symptoms and prevent osteoporosis. (Level I)
  4. SERMS should not be used in women at high risk of thrombosis because they increase the risk of VTEs, similar to oral estrogen therapy. (Level I)

SELECTIVE SEROTONIN REUPTAKE INHIBITORS AND SEROTONIN NOREPINEPHRINE REUPTAKE INHIBITORS

Key Points

  1. Several selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) decrease the frequency and severity of vasomotor symptoms in postmenopausal women.
  2. The SSRI paroxetine is the first nonhormonal medication to be government approved for the treatment of vasomotor symptoms. The approved dose (paroxetine 7.5 mg) is lower than the doses of paroxetine approved for the treatment of depression.
  3. Although randomized, controlled trials demonstrate efficacy greater than placebo for other SSRIs and SNRIs, including venlafaxine and escitalopram, and other doses of paroxetine, these formulations are not currently approved for the treatment of vasomotor symptoms.
  4. Some SSRIs and SNRIs inhibit the cytochrome P450 enzyme system and may render tamoxifen less effective.

Recommendations for Clinical Care

  1. Midlife women with bothersome vasomotor symptoms may consider the use of an SSRI or SNRI for the treatment of vasomotor symptoms; paroxetine 7.5 mg is the only nonhormonal agent government approved for this indication. (Level I)
  2. Women using tamoxifen for the prevention or treatment of breast cancer should avoid the use of paroxetine for management of vasomotor symptoms. (Level II)
  3. Use of an SSRI or SNRI for the treatment of vasomotor symptoms should be individualized, based on a woman’s medical history, personal preferences, and the overall risk-benefit assessment. (Level II)

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