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Divigel (Estradiol Topical) - Summary

 


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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, 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.

 

DIVIGEL SUMMARY

Divigel®
(estradiol gel) 0.1%

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.


See all Divigel indications & dosage >>

DIVIGEL NEWS HIGHLIGHTS

Published Studies Related to Divigel (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]

Prediction of incident osteoporotic fractures in elderly women using the free estradiol index. [2005.02]

Serum concentrations of 17beta-estradiol and estrone after multiple-dose administration of percutaneous estradiol gel in symptomatic menopausal women. [2001.04]

Effect of an estradiol gel with monthly or quarterly progestogen on menopausal symptoms and bleeding. [2000.12]

Estradiol and progesterone regulate the proliferation of human breast epithelial cells. [1998.05]

more >>

Clinical Trials Related to Divigel (Estradiol Topical)

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients [Recruiting]

Postpartum Depression: Transdermal Estradiol Versus Sertraline [Recruiting]

Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer [Recruiting]

Effect of 17ß-Estradiol on Inflammatory-Immune Responses in Post-Menopausal Women According to Administration Route [Recruiting]

Clinical Estradiol Trial in Women With Schizophrenia [Recruiting]

more >>

DIVIGEL PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Divigel has an overall score of 9. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

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.

See all Divigel reviews / ratings >>

Page last updated: 2006-11-04

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