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Delestrogen (Estradiol Valerate) - Summary

 

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WARNINGS

  1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN.

    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 no evidence that “natural” estrogens are more or less hazardous than “synthetic” estrogens at equiestrogenic doses.

  2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.

    There is no indication for estrogen therapy during pregnancy or during the immediate postpartum period. Estrogens are ineffective for the prevention or treatment of threatened or habitual abortion. Estrogens are not indicated for the prevention of postpartum breast engorgement.

    Estrogen therapy during pregnancy is associated with an increased risk of congenital defects in the reproductive organs of the fetus, and possibly other birth defects. Studies of women who received diethylstilbestrol (DES) during pregnancy have shown that female offspring have an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal cancer later in life; male offspring have an increased risk of urogenital abnormalities and possibly testicular cancer later in life. The 1985 DES Task Force concluded that use of DES during pregnancy is associated with a subsequent increased risk of breast cancer in the mothers, although a causal relationship remains unproven and the observed level of excess risk is similar to that for a number of other breast cancer risk factors.

 

DELESTROGEN SUMMARY

DELESTROGEN®
(estradiol valerate injection, USP)

DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil.

DELESTROGEN (estradiol valerate injection, USP) is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. There is no adequate evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause and they should not be used to treat these conditions.

  2. Treatment of vulval and vaginal atrophy.

  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.

  4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

DELESTROGEN NEWS HIGHLIGHTS

Media Articles Related to Delestrogen (Estradiol)

Hormone Cream Smoothes Skin Not Damaged by Sun
Source: MedPage Today Dermatology [2008.09.15]

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

more>>

Published Studies Related to Delestrogen (Estradiol)

Serum uric acid concentration as non-classic cardiovascular risk factor in women with polycystic ovary syndrome: effect of treatment with ethinyl-estradiol plus cyproterone acetate versus metformin. [2008.07]

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

The effect of short-term estradiol therapy on clotting and inflammatory markers in older men receiving hormonal suppression therapy for prostate cancer. [2008.06]

Does self-administered vaginal misoprostol result in cervical ripening in postmenopausal women after 14 days of pre-treatment with estradiol? Trial protocol for a randomised, placebo-controlled sequential trial. [2008.06]

Effects in postmenopausal women of estradiol and medroxyprogesterone alone and combined on resistance artery function and endothelial morphology and movement. [2008.05]

more>>

Clinical Trials Related to Delestrogen (Estradiol)

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: 2008-09-15

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