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
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
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.
Kronenberg F. Hot flashes: epidemiology and physiology.
Ann NY Acad Sci. 1990;592:52-86.
Longcope C. Hormone
dynamics at the menopause. Ann NY Acad
Sci. 1990;592:21-30.
Graziottin
A. Sexual desire disorders: Clinical approach. Urodinamica.
2004;14:61-67.
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.
Kupperman HS, Wetchler
BB, Blatt MHG. Contemporary therapy of the menopausal syndrome.
JAMA.1989;171:1627-37.
Freedman RR. Pathophysiology and
treatment of menopausal hot flashes. Semin
Reprod Med. 2005;23(2):117-125.
