BOXED WARNING
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogen 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 estrogenic doses.
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or 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 and medroxyprogesterone acetate, 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. 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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ESTRASORB SUMMARY
Rx only
Prescribing Information
Estrasorb® (estradiol topical emulsion) is designed to deliver estradiol to the blood circulation following topical application of an emulsion. Each gram of Estrasorb contains 2.5 mg of estradiol hemihydrate USP, EP, which is encapsulated using a micellar nanoparticle technology. Estrasorb is packaged in foil pouches containing 1.74 grams of drug product. Daily topical application of the contents of two foil pouches provides systemic delivery of 0.05 mg of estradiol per day.
Estrasorb is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.
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NEWS HIGHLIGHTSMedia Articles Related to Estrasorb (Estradiol Topical)
Hormone Replacement Therapy Tied to Hearing Loss
Source: MedicineNet Deafness Specialty [2017.05.15]
Title: Hormone Replacement Therapy Tied to Hearing Loss
Category: Health News
Created: 5/12/2017 12:00:00 AM
Last Editorial Review: 5/15/2017 12:00:00 AM
Published Studies Related to Estrasorb (Estradiol Topical)
Pharmacokinetics of testosterone and estradiol gel preparations in healthy young
men. [2013]
The paucity of pharmacokinetic data on testosterone gel formulations and absence
of such data on estradiol administration in healthy young men constitutes a
fundamental gap of knowledge in behavioral endocrinological research. We
addressed this issue in a double-blind and placebo controlled study in which we
applied a topical gel containing either 150mg of testosterone (N=10), 2mg of
estradiol (N=8) or a respective placebo (N=10) to 28 healthy young men...
The use of oestradiol therapy in postmenopausal women after TVT-O anti-incontinence surgery. [2010.05]
OBJECTIVE: To investigate whether patients who were treated with TVT-O procedure for urodynamic stress incontinence had a significant improvement in their urodynamic findings and their post-operative symptoms (frequency, urgency, nocturia) if they were treated post-operatively with vaginal oestradiol for 6 months compared to the non-treated group... CONCLUSION: It appears that vaginal oestradiol treatment could be offered to postmenopausal patients after a TVT-O procedure having the symptoms of frequency and urgency provided they are aware of the lack of evidence regarding long term benefit. Copyright 2010. Published by Elsevier Ireland Ltd.
Estradiol in micellar nanoparticles: the efficacy and safety of a novel transdermal drug-delivery technology in the management of moderate to severe vasomotor symptoms. [2006.03]
OBJECTIVE: To assess the efficacy and safety of topical micellar nanoparticle estradiol emulsion (MNPEE; Estrasorb; Novavax, Inc., Malvern, PA) in postmenopausal women with moderate to severe vasomotor symptoms... CONCLUSION: Once-daily application of 3.45 g of micellar nanoparticle estradiol emulsion containing 8.6 mg of estradiol was safe and effective in providing significant relief of vasomotor symptom frequency and severity in postmenopausal women.
Prediction of incident osteoporotic fractures in elderly women using the free estradiol index. [2005.02]
A decline in postmenopausal estrogen concentration accelerates postmenopausal bone loss. We have examined the predictive power of endogenous estrogen production, DXA hip bone density (BMD), and heel quantitative ultrasound (QUS) on incident clinical fracture in a prospective 3-year population based, randomised controlled trial of calcium supplementation...
Serum concentrations of 17beta-estradiol and estrone after multiple-dose administration of percutaneous estradiol gel in symptomatic menopausal women. [2001.04]
In two multicenter phase III efficacy studies, blood samples were obtained to evaluate the serum concentrations of 17beta-estradiol (E2) and unconjugated estrone (E1) after administration of a percutaneous gel or transdermal patch containing estradiol... However, the 0.625-g gel dose did not produce E2 levels in a range expected to be consistently therapeutic in most postmenopausal women.
Clinical Trials Related to Estrasorb (Estradiol Topical)
Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms [Completed]
The purpose of this study is to determine the efficacy and safety of a topical estradiol gel
for the treatment of hot flushes in postmenopausal women.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Estrasorb has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Estrasorb review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopausal hot flashes |
| Dosage & duration: | | 2.5 mg 2 times/day taken 2 per day for the period of 1 year |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Hot flashes were totally diminished. |
| Side effects: | | None so far that I am aware of. |
| Comments: | | This product is a bio-identical cream rubbed onto the skin, containing 2.5 grams estradiol per package. I was reluctant to take estrogen orally and this was a viable alternative. The cream is rubbed into the thigh morning and evening for about 3 minutes. Sunscreen is to be avoided in the area where the cream is applied since it can affect/prevent effective absorption. |
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| | Estrasorb review by 42 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | 3.5 grams daily (dosage frequency: daily) for the period of 1 year |
| Other conditions: | | hot flashes, night sweats, vaginal dryness |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | completely changed my way of life... within days, could tell a difference... no longer suffer from night sweats or hot flashes at all, the best thing i have ever tried.. this is a topical lotion that comes in individual packets that are 1.74 grams each (daily dosage is 2 packets) |
| Side effects: | | none |
| Comments: | | use 2 packets daily, rubs into skin like a lotion.. |
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Page last updated: 2017-05-15
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