First Transdermal Gel for Estrogen Therapy in the United States
The U.S. Food and Drug Administration (FDA) has approved EstroGel 0.06% (estradiol gel)—the first plant-based, transdermal estrogen gel formulation in the country that is similar to estrogen your body makes naturally—for the treatment of moderate to severe hot flashes and moderate to severe dryness, itching, and burning in and around the vagina.
The only FDA-approved estrogen therapy available in gel form, EstroGel provides women with a once-daily estradiol treatment option that is similar to the estrogen naturally produced by a woman's body. EstroGel is also marketed in Europe.
The transdermal delivery of EstroGel allows the body to receive a consistent and continuous supply of estrogen.* EstroGel is applied once daily on one arm from wrist to shoulder. The gel dries in as little as two to five minutes.* EstroGel will be prescribed at a 1.25g daily dose.* EstroGel is packaged in a non-aerosol, metered-dose pump that is designed to deliver 1.25g of gel per compression.
EstroGel*is available by prescription only. Ask your healthcare provider if EstroGel is right for you.
To learn more about EstroGel, the first transdermal gel for estrogen therapy, visit our web site at www.estrogel.com.
Important Safety Information
Patients should not use EstroGel if they have unusual vaginal bleeding, currently have or have had certain cancers (including breast and cancer of the uterus), have had a stroke or heart attack in the last year, currently have or have had blood clots (e.g., in the legs), currently have or have had liver problems, are allergic to EstroGel or any of its ingredients, are or may be pregnant or are breastfeeding.
Estrogens with or without progestins should not be used to prevent heart attacks or heart disease.* In clinical studies, estrogens given in combination with progestins have been reported to increase the risk of heart attacks, stroke, breast cancer, blood clots in menopausal women.* Because of these risks, the lowest dose that relieves symptoms should be used and should be given for the shortest duration possible.
Close monitoring of all women taking estrogens is important.* Estrogens increase the chances of getting cancer of the uterus.* Please see your healthcare professional if you are taking an estrogen and have continued or intermittent vaginal bleeding.*
EstroGel should be used in combination with a progestin in women with an intact uterus.* There is no evidence to support that "natural" estrogens are safer than synthetic derived estrogens with regard to risks for endometrial cancer (lining of the uterus).
The commonly reported side effects are those typical of estrogen therapy:* headache, breast pain, irregular vaginal bleeding or spotting, stomach cramps/bloating, nausea and vomiting, hair loss.
Licensed medical practitioners may request EstroGel samples. Click on the Sample Request Form link in the right-hand column for more information. For complete safety and prescribing information, please click on the Patient and Prescribing Information links on the right.
