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.
|
| |
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.
|
NEWS HIGHLIGHTSMedia Articles Related to Estrasorb (Estradiol Topical)
AACE Issues New Medical Guidelines For Proper And Ethical Use Of Growth Hormone
Source: Endocrinology News From Medical News Today [2009.11.04]
The American Association of Clinical Endocrinologists (AACE) released new medical guidelines for the accurate diagnosis and effective ethical treatment of growth hormone deficiency in affected patients. Growth hormone replacement therapy has proven useful for children and adults with scientifically proven growth hormone deficiency.
Published Studies Related to Estrasorb (Estradiol Topical)
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.
Estradiol and progesterone regulate the proliferation of human breast epithelial cells. [1998.05]
OBJECTIVE: To study the effects of estradiol and progesterone on the proliferation of normal human breast epithelial cells in vivo...
Treatment of menopausal keratoconjunctivitis sicca with topical oestradiol. [1998.01]
OBJECTIVE: To investigate the effect of 17 beta-oestradiol ophthalmic drops in comparison with a traditional tear substitute in postmenopausal women with keratoconjunctivitis sicca. DESIGN: Randomised prospective trial. SETTING: Menopause clinic. PARTICIPANTS: Eighty-four postmenopausal women suffering from keratoconjunctivitis sicca and necessitating a hormone replacement therapy (HRT) for general climacteric symptoms... CONCLUSIONS: Our study demonstrates that topical oestrogen is successful in treating keratoconjunctivitis sicca while it seems that the blood-eye barrier prevents systemic oestrogens from acting on the conjunctivae.
Clinical Trials Related to Estrasorb (Estradiol Topical)
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.
|
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. |
|
| | 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.. |
|
|
|
Page last updated: 2009-11-04
|
