When Moderate to Severe Vasomotor Symptoms Persist on Estrogen Alone

 

Safety Information
Covaryx® and Covaryx® H.S. (esterified estrogen and methyltestosterone tablets) are indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause in those patients not improved by estrogens alone. This product has a black box warning because prolonged exposure to exogenous estrogens has been reported to increase the risk of endometrial carcinoma in postmenopausal women. The risk correlates to both duration of treatment and the amount of the estrogen dose. In addition, estrogens should not be used during pregnancy. Covaryx and Covaryx H.S, tablets contain estrogen but do not contain a progestin. Estrogens should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women, Estrogens should not be used in women with breast cancer, estrogen-dependent neoplasia, abnormal genital bleeding, thrombophlebitis, or thrombosis. Methyltestosterone, a synthetic form of testosterone, should not be used when severe liver damage is present or in pregnant and/or breastfeeding mothers.

 

Covaryx® offers an additional treatment choice for menopausal women:

  • Who have failed to achieve significant relief from estrogen-only therapy
    • Some women who are on estrogen therapy may continue to experience persistent vasomotor symptoms.1, 2

 

Androgen levels may decrease during menopause3:

  • Bilateral oophorectomy triggers a 70% reduction in androgens.4

 

Estrogen/androgen combination therapy demonstrates symptom relief5:

  • Vasomotor symptoms relief with low dose estrogen/androgen therapy was simliar to relief experienced with high dose estrogen-only therapy.5
    • Decrease in hot flashes were recorded daily
    • Repeated measurements of symptoms were analyzed for changes
    • Symptoms recorded with a modified Kupperman Menopausal Symptom Scale6

 

 

Covaryx® brings together the benefits of estrogen and androgen in one dose:

  • Provides relief from vasomotor symptoms5
  • Replaces lost androgens5

 

The Thermoneutral Zone7

Women who suffer from hot flashes have been shown to have a "virtually nonexistent" or narrow Thermoneutral Zone. The Thermoneutral Zone regulates the core body temperature, making appropriate adjustments when the body is either hot or cold. The loss of estrogen has been found to decrease the Thermoneutral Zone in women, making them more sensitive to minor temperature fluctuations.7

 

Important Patient Information

For Important Patient Information click here.

 

Prescribing Information

For complete Prescribing Information click here.

 

References

  1. Brunton SA. Estrogen replacement therapy (ERT): results of a patient satisfaction survey of women receiving ERT and implicatlons for treatment, Todays Ther Trends, 1996;14(3):119-30.
  2. Kronenberg F. Hot flashes: epidemiology and physiology. Ann NY Acad Sci. 1990;592:52-86.
  3. Longcope C. Hormone dynamics at the menopause. Ann NY Acad Sci. 1990;592:21-30.
  4. Graziottin A. Sexual desire disorders: Clinical approach. Urodinamica. 2004;14:61-67.
  5. Simon J, Klaiber E, Wiita B, et al. Differential effects of estrogen-androgen and estrogen-only therapy on vasomotor symptoms, gonadotropin secretion, and endogenous androgen bioavailability in postmenopausal women. Menopause. 1999;6(2):138-46.
  6. Kupperman HS, Wetchler BB, Blatt MHG. Contemporary therapy of the menopausal syndrome. JAMA.1989;171:1627-37.
  7. Freedman RR. Pathophysiology and treatment of menopausal hot flashes. Semin Reprod Med. 2005;23(2):117-125.

 

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