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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 no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, 2. Malignant neoplasms, a. Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, 1. Cardiovascular disorders.)
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 (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. 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.
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ESTRACE SUMMARY
Each gram of ESTRACE® (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone.
ESTRACE (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of vulvar and vaginal atrophy.
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ESTRACE NEWS HIGHLIGHTS
Published Studies Related to Estrace (Estradiol Vaginal)
Effect of raloxifene and low-dose percutaneous 17beta-estradiol on menopause symptoms and endometrium-A randomized controlled trial. [2009.01.20]
OBJECTIVE: To investigate the effects on climacteric symptoms and endometrium of percutaneous low-dose 17beta-estradiol associated with raloxifene in postmenopausal women... CONCLUSIONS: The association of percutaneous low dose of 17beta-estradiol with raloxifene exerted favorable effects on hot flushes severity of postmenopausal women, providing a safe profile in endometrium at least in short-term therapy.
Estradiol supplementation during the luteal phase of IVF-ICSI patients: a randomized, controlled trial. [2008.12]
OBJECTIVE: To evaluate the effectiveness of transdermal E(2) administration in the luteal phase of IVF/ICSI cycles...
Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. [2008.11]
OBJECTIVE: To evaluate the efficacy of ultra-low-dose 10-microgram 17beta-estradiol (E2) vaginal tablets for treatment of vaginal atrophy... CONCLUSION: After 12 weeks of treatment, an ultra-low-dose 10-microgram E2 vaginal tablet, compared with placebo, demonstrated significant improvement for the primary endpoints: vaginal cytology and pH and most bothersome urogenital symptoms score. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT00108849 LEVEL OF EVIDENCE: I.
Effects of conventional or extended-cycle regimen of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on various hemostasis parameters. [2008.11]
BACKGROUND: The study was conducted to investigate the effect of a combined oral contraceptive (COC) containing 30 mcg ethinylestradiol and 2 mg dienogest with two different regimens on various hemostasis variables... CONCLUSION: In general, these results were in agreement with those observed during treatment with other COCs. The study demonstrated that during conventional and extended-cycle treatment with EE/DNG, a steady-state in the effects on hemostasis variables was reached within 3 months, and that the effects observed after 3 and 12 months of treatment did not substantially differ between conventional and extended-cycle regimen.
Metabolic syndrome in postmenopausal women: the influence of oral or transdermal estradiol on inflammation and coagulation markers. [2008.11]
OBJECTIVE: The objective of the study was to determine whether the route of administration of estrogen therapy in women with metabolic syndrome (MBS) influences inflammation and coagulation parameters... CONCLUSION: Postmenopausal women with MBS have higher levels of certain coagulation and inflammation markers and different responses to oral compared with transdermal estradiol.
Clinical Trials Related to Estrace (Estradiol Vaginal)
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8
weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the
relief of vasomotor symptoms and who have hypertension.
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]
The primary objective of this study was to compare the adhesive quality of a new formulation
of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following
a single system application in 80 healthy postmenopausal female volunteers. As a secondary
objective, primary dermal irritation was assessed after removal of each transdermal system.
Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch [Completed]
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and
exclusion criteria will be enrolled in the study. The women will be randomly assigned to one
of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch
once a week for 12 weeks.
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]
Prostate cancer is the most commonly diagnosed cancer among males in the U. S. More than
220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000
will die of this disease.
Androgen deprivation, the elimination of testosterone and its active metabolites, remains the
single most effective intervention available for the treatment of advanced prostate
carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate
cancer, which is usually short-lived. Estradiol induces activation of many arms of the
immune system and may be a more effective and long lasting means of inducing immunity to
prostate tissue.
This study will treat clinically localized prostate cancer patients with either estrogens, or
standard androgen deprivation without estrogens, prior to prostatectomy in order more
completely to describe immune regulation by estradiol in men. Control tissue from patients
who have not been treated with androgen deprivation will be procured from the Northwest
Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons
against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue
samples and blood samples will be assessed for immune system changes.
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ESTRACE PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Estrace has an overall score of 9.50. The effectiveness score is 9 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
| | Estrace review by 57 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | .05mg taken once daily for the period of three years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no mood swings or hot flsshes |
| Side effects: | | moderate weight gain |
| Comments: | | take one pill daily |
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| | Estrace review by 53 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menapause |
| Dosage & duration: | | 1mg taken once daily for the period of 3years |
| Other conditions: | | night sweats |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no hot flashes and decrease in night sweats |
| Side effects: | | none |
| Comments: | | one tablet in the AM |
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Page last updated: 2009-02-07
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