Important Risk Information
Prescribing Information
Patient Information
For Patients

Why Choose EstroGel?

The power of ONE.

One Gel. Two Indications.

EstroGel® 0.06% (estradiol gel) is the first and only non-patch, non-film transdermal estrogen indicated for treatment of both1

Moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause*
*

When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.1

Moderate to severe vasomotor symptoms (VMS) due to menopause

Moderate to severe symptoms of VVA due to menopause may include vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, and vaginal pain associated with sexual activity.2

One Transdermal Application per Day.

EstroGel avoids first-pass liver metabolism, delivering estrogen through the skin into the bloodstream. The clinical significance of avoiding first-pass liver metabolism and the effect of transdermal delivery have not been determined.1

Estrogen-alone therapy may increase the risks of stroke, deep vein thrombosis, endometrial cancer and dementia, and estrogen plus progestin therapy may increase the risks of invasive breast cancer, deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction and dementia.1

One Simple List of Ingredients.

EstroGel contains 5 ingredients.1

One Pump. One Dose.

One pump depression of EstroGel 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol.1

One Arm. No Rotation.

EstroGel is applied to the entire arm on the inside and outside from wrist to shoulder. No application site rotation is required.1

One Invisible Option.

EstroGel is a clear, colorless gel. After application to skin, EstroGel dries in 2 to 5 minutes. Once dried, EstroGel is invisible.

One Low Rate of Application Site Reactions.

In 2 controlled clinical trials, only 0.6% of patients who received EstroGel 1.25 g reported application site reactions.1

Inform postmenopausal women of possible less serious adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea, and vomiting.1

One Hour On, No Measurable Transfer.

One hour after gel application in a clinical study, there was no measurable transfer of estradiol to nondosed healthy postmenopausal females (n=24) after direct skin-to-skin contact with subjects administered EstroGel.1

One Consistent Level All Day.

EstroGel has an approximately 36-hour half-life. Serum concentrations appeared to reach steady state after 3 days.1†

†

Steady state achieved after the third daily application of a 2.5-g dose of EstroGel (1.25 g on each arm); dose not approved in the United States (EstroGel Prescribing Information, Section 12.3).1

One Rate-Limiting Factor.

When EstroGel is applied to skin, the rate-limiting factor for transport of estradiol into systemic circulation is the rate of diffusion across the stratum corneum.1

One Option Patients Prefer.

9 out of 10 patients surveyed online (88% of 890 responding) are satisfied to extremely satisfied with EstroGel.3‡

9 out of 10 patients surveyed online (89% of 620 responding) prefer EstroGel over their previous hormone therapy.3‡

‡

Survey sponsored by ASCEND Therapeutics.

EstroGel is tried and tested

70 years. 40 countries. 55 publications.

EstroGel is tried and tested

Approved to treat some menopausal symptoms in 70 countries4§

Used worldwide for more than 40 years4§

Well studied (more than 55 publications)4§
§

Includes dosages, formulations, and indications that are not approved in the United States. EstroGel was approved for use in the US in 2004.4

What’s going unsaid? Your patients may not know how to start the conversation.

Learn how you can help

Did you know your patients can save up to $35 on their EstroGel prescription?

Find out how

Order samples or patient education materials: contact your local EstroGel representative or call ASCEND Therapeutics at 1-855-786-0738.

References: 1. EstroGel [package insert]. Herndon, VA: ASCEND Therapeutics; 2020. 2. Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms—recommendations for clinical evaluation. Draft guidance. Washington, DC; US Department of Health and Human Services; January 2003. 3. Simon JA, Mackowiak JI. Independent web-based vs “meaningful use” patient portals in assessing patient-reported outcomes: the estradiol gel 0.06% case study. Sex Reprod Menopause. October 2011;(suppl):1-9. 4. Data on file, ASCEND Therapeutics.

Indication

EstroGel® 0.06% (estradiol gel) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.

Important Risk Information about EstroGel1

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of 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 daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

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.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.

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.

EstroGel is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active arterial thromboembolic disease, or a history of these conditions; known anaphylactic reaction or angioedema to EstroGel; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; known or suspected pregnancy.

Increase in the risk of breast cancer, ovarian cancer, gallbladder disease, severe hypercalcemia in patients with breast cancer and bone metastases, visual abnormalities such as retinal vascular thrombosis, elevated blood pressure, hypertriglyceridemia, hypothyroidism, fluid retention, and hypocalcemia have been reported in patients receiving estrogens.

Estrogens may cause an exacerbation of endometriosis, symptoms of angioedema in women with hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. Use with caution in women with past history of cholestatic jaundice, and in the case of recurrence, medication should be discontinued. Moisturizer lotion application 1 hour after EstroGel application significantly increased estradiol absorption. Alcohol-based gels are flammable. Avoid fire, flame, or smoking until the gel has dried.

In clinical studies, the most commonly reported adverse events for EstroGel were breast pain, headache, and flatulence.

REFERENCE: 1. EstroGel 0.06% [package insert]. Herndon, VA: ASCEND Therapeutics US, LLC; 2020.

Please see full Prescribing Information, including Boxed Warnings.

INDICATION

EstroGel® 0.06% (estradiol gel) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.

IMPORTANT RISK INFORMATION about EstroGel1

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of 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 daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

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.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.

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.

EstroGel is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active arterial thromboembolic disease, or a history of these conditions; known anaphylactic reaction or angioedema to EstroGel; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; known or suspected pregnancy.

Increase in the risk of breast cancer, ovarian cancer, gallbladder disease, severe hypercalcemia in patients with breast cancer and bone metastases, visual abnormalities such as retinal vascular thrombosis, elevated blood pressure, hypertriglyceridemia, hypothyroidism, fluid retention, and hypocalcemia have been reported in patients receiving estrogens.

Estrogens may cause an exacerbation of endometriosis, symptoms of angioedema in women with hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. Use with caution in women with past history of cholestatic jaundice, and in the case of recurrence, medication should be discontinued. Moisturizer lotion application 1 hour after EstroGel application significantly increased estradiol absorption. Alcohol-based gels are flammable. Avoid fire, flame, or smoking until the gel has dried.

In clinical studies, the most commonly reported adverse events for EstroGel were breast pain, headache, and flatulence.

REFERENCE: 1. EstroGel 0.06% [package insert]. Herndon, VA: ASCEND Therapeutics US, LLC; 2020.

Please see full Prescribing Information, including Boxed Warnings.