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Vagifem (Estradiol Vaginal) - Summary

 


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BOX WARNING

ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA.

Three independent, case controlled studies have reported an increased risk of endometrial cancer in post-menopausal women exposed to exogenous estrogens for more than one year. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incident rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer-reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade.

The three case-controlled studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose.

In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed, on at least a semi-annual basis, to determine the need for continued therapy.

Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or reoccurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.

There is no evidence at present that “natural” estrogens are more or less hazardous than “synthetic” estrogens at equi-estrogenic doses.

 

VAGIFEM SUMMARY

VAGIFEM® (ESTRADIOL VAGINAL TABLETS)

VAGIFEM® (estradiol vaginal tablets) are small, white, film-coated tablets containing 25.8µg of estradiol hemihydrate equivalent to 25µg of estradiol.

VAGIFEM® is indicated for the treatment of atrophic vaginitis.


See all Vagifem indications & dosage >>

VAGIFEM NEWS HIGHLIGHTS

Published Studies Related to Vagifem (Estradiol Vaginal)

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

The effect of luteal phase vaginal estradiol supplementation on the success of in vitro fertilization treatment: a prospective randomized study. [2008.03]

Efficacy of Low-Dose Estradiol Vaginal Tablets in the Treatment of Atrophic Vaginitis: A Randomized Controlled Trial. [2008.01]

The effect of luteal phase vaginal estradiol supplementation on the success of in vitro fertilization treatment: a prospective randomized study. [2007.08.01]

One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women. [2007.06.20]

more >>

Clinical Trials Related to Vagifem (Estradiol Vaginal)

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 Climara® 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: 2008-03-26

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