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Vivelle (Estradiol Transdermal) - Summary

 


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ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is currently no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.

CARDIOVASCULAR AND OTHER RISKS

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease.

The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies). Other doses of conjugated estrogens with medroxyprogesterone, and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar for all estrogens and estrogen-progestin combinations. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

 

VIVELLE SUMMARY

The Vivelle® (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin.

Vivelle is indicated in the following:

  1. Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
  2. Treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
  3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
  4. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risks of osteoporosis and non-estrogen medications should be carefully considered.
    The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.


See all Vivelle indications & dosage >>

VIVELLE NEWS HIGHLIGHTS

Media Articles Related to Vivelle (Estradiol Transdermal)

FDA Drug and Device Approvals: June 10, 2004
Source: Medscape Pharmacotherapy Headlines [2004.06.10]

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Published Studies Related to Vivelle (Estradiol Transdermal)

Transdermal estradiol reduces F2alpha-isoprostane levels in postmenopausal women. [2008.07]

Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. [2008.06]

A comparison of the short-term effects of oral conjugated equine estrogens versus transdermal estradiol on C-reactive protein, other serum markers of inflammation, and other hepatic proteins in naturally menopausal women. [2008.05]

The effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women. [2008.03]

Estradiol supplementation during the luteal phase of IVF-ICSI patients: a randomized, controlled trial. [2008.01.11]

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Clinical Trials Related to Vivelle (Estradiol Transdermal)

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]

Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climaraź Transdermal System 0.025 mg/Day [Completed]

Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch [Completed]

Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination [Completed]

Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer [Completed]

more >>

Page last updated: 2008-11-02

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