In women, oral conjugated estrogens USP and synthetic conjugated estrogens A are used for the management of moderate to severe vasomotor symptoms associated with menopause and for the management of vulvar and vaginal atrophy (atrophic vaginitis). If estrogens are used solely for the management of vulvar and vaginal atrophy, use of topical vaginal preparations should be considered. Synthetic conjugated estrogens B is used for the management of moderate to severe vasomotor symptoms and for the management of severe vaginal dryness, pain with sexual intercourse, and symptoms of vulvar and vaginal atrophy associated with menopause. Oral conjugated estrogens USP also is used for the management of female hypoestrogenism secondary to hypogonadism, castration, or primary ovarian failure.
Oral conjugated estrogens USP is used adjunctively with other therapeutic measures (e.g., diet, calcium, weight-bearing exercise [including walking, running], physical therapy) to retard further bone loss and the progression of osteoporosis associated with estrogen deficiency in postmenopausal women. While estrogen replacement therapy is effective for the prevention of osteoporosis in women and has been shown to reduce bone resorption and retard or halt bone loss in postmenopausal women, such therapy is associated with a number of adverse effects. If prevention of postmenopausal osteoporosis is the sole indication for therapy with oral conjugated estrogens, alternative therapy (e.g., alendronate, raloxifene, risedronate) should be considered.
Another therapeutic option involves use of conjugated estrogens in combination with an estrogen agonist-antagonist (bazedoxifene) for the management of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis. The combination of conjugated estrogens with bazedoxifene is referred to as a tissue-selective estrogen complex (TSEC).
While results from earlier observational studies indicated that estrogen replacement therapy (ERT) or combined estrogen/progestin therapy (hormone replacement therapy, HRT) was associated with cardiovascular benefit in postmenopausal women, results of the Heart and Estrogen/progestin Replacement Study (HERS) evaluating estrogen/progestin and the Women's Health Initiative (WHI) study evaluating estrogen alone and estrogen/progestin therapy indicate that hormone therapy does not decrease the incidence of cardiovascular disease. The American Heart Association (AHA), American College of Obstetricians and Gynecologists (ACOG), FDA, and manufacturers recommend that hormone therapy not be used to prevent heart disease in healthy women (primary prevention) or to protect women with preexisting heart disease (secondary prevention).
Oral conjugated estrogens USP is used for the palliative treatment of advanced, inoperable, metastatic carcinoma of the breast in postmenopausal women and in men. Estrogens are one of several second-line agents that can be used in certain postmenopausal women with metastatic breast cancer.
Oral conjugated estrogens USP is used for the palliative treatment of advanced carcinoma of the prostate in men; however, the risk of adverse cardiovascular effects of estrogens must be considered.
Conjugated estrogens USP may be administered IM or IV for the treatment of abnormal uterine bleeding caused by hormonal imbalance not associated with organic pathology.
Conjugated estrogens USP may be administered intravaginally for the management of atrophic vaginitis or kraurosis vulvae.
Although in the past oral conjugated estrogens has been used for the prevention of postpartum breast engorgement, the FDA has withdrawn approval of estrogen-containing drugs for this indication since estrogens have not been shown to be safe for use in women with postpartum breast engorgement. Data from controlled studies indicate that the incidence of substantial painful engorgement is low in untreated women, and the condition usually responds to appropriate analgesic or other supportive therapy.