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, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See
CLINICAL STUDIES
and
WARNINGS, Cardiovascular disorders
and
Dementia.)
The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See
CLINICAL STUDIES
and
WARNINGS, Cardiovascular disorders.)
The estrogen-plus-progestin substudy of the WHI reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See
CLINICAL STUDIES
and
WARNINGS, Cardiovascular disorders
and
Malignant neoplasms,
Breast cancer
.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See
CLINICAL STUDIES, WARNINGS, Dementia, and
PRECAUTIONS, Geriatric Use.)
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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DIVIGEL SUMMARY
Divigel® (estradiol gel) 0.1% is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin, quick-drying layer.
Divigel® (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause.
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NEWS HIGHLIGHTS
Published Studies Related to Divigel (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.
Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. [2009.01]
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of three doses of estradiol gel 0.1% (Divigel, a novel formulation consisting of 1 mg estradiol per 1 g transdermal gel) to reduce the frequency and severity of vasomotor symptoms and signs of vulvar and vaginal atrophy associated with menopause... CONCLUSIONS: Low-dose transdermal estradiol gel 0.1% is an effective treatment for relief of vasomotor symptoms, as well as signs of vulvar and vaginal atrophy, associated with menopause. Estradiol gel 0.1% offers multiple dosing options to individualize patient therapy, including the lowest available effective dose (0.25 mg estradiol, delivering 0.003 mg/d estradiol) to treat the vasomotor symptoms of menopause.
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...
Clinical Trials Related to Divigel (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 4 ratings/reviews, Divigel has an overall score of 9.75. The effectiveness score is 9.50 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Divigel review by 48 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | vaginal dryness, night sweats |
| Dosage & duration: | | 0.1% 0.5 mg taken once daily for the period of 3 months so far |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | The Night sweats are almost non-existent now - occurring very irregularly and the vaginal dryness is remarkably better. |
| Side effects: | | I have found no side effects so far. |
| Comments: | | Application of one gel packet once daily to either thigh. I have found that during one week of the month when the vaginal dryness is at it's peak it helps to use two packets. This was approved by my physician. |
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| | Divigel review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | HRT |
| Dosage & duration: | | 0.1% (dosage frequency: everyday) for the period of 1 month |
| Other conditions: | | Depression |
| Other drugs taken: | | Lexapro and Seroquel | | |
Reported Results |
| Benefits: | | This worked better than an estrogen patch. I felt better and vagainal atrophy was almost cleared up. |
| Side effects: | | None that I can tell. |
| Comments: | | Rub one packet of gel on the top of either thigh daily. |
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| | Divigel review by 44 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | HRT |
| Dosage & duration: | | 0.1% (dosage frequency: everyday) for the period of 1 month |
| Other conditions: | | Depression |
| Other drugs taken: | | Lexapro and Seroquel | | |
Reported Results |
| Benefits: | | This worked better than an estrogen patch. I felt better and vagainal atrophy was almost cleared up. |
| Side effects: | | None that I can tell. |
| Comments: | | Rub one packet of gel on the top of either thigh daily. |
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Page last updated: 2014-11-30
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