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 progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed, persistent, or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable 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.

Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.

Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.

Prescribe estrogens with or without progestogens 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

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.

Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestin therapy, taking into account her individual risk profile.

Prescribe estrogens with or without progestogens 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; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to EstroGel; Hepatic impairment or disease; Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Increase in the risk of breast cancer, ovarian cancer, gallbladder disease, severe hypercalcemia in women with breast cancer and bone metastases, visual abnormalities such as retinal vascular thrombosis, elevated blood pressure, exacerbation of hypertriglyceridemia, exacerbation of 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. Consider whether the benefits of estrogen therapy outweigh the risks in women with these conditions. Use with caution in women with past history of cholestatic jaundice, and in the case of recurrence, discontinue EstroGel. Women on thyroid-replacement therapy may require higher doses of thyroid hormone.

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 common adverse reactions with EstroGel (≥ 5 percent) were breast pain, headache, and flatulence.

REFERENCES: 1. EstroGel 0.06% [package insert]. Herndon, VA: ASCEND Therapeutics US, LLC; 2021.

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 progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed, persistent, or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable 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.

Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.

Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.

Prescribe estrogens with or without progestogens 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

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.

Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestin therapy, taking into account her individual risk profile.

Prescribe estrogens with or without progestogens 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; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to EstroGel; Hepatic impairment or disease; Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Increase in the risk of breast cancer, ovarian cancer, gallbladder disease, severe hypercalcemia in women with breast cancer and bone metastases, visual abnormalities such as retinal vascular thrombosis, elevated blood pressure, exacerbation of hypertriglyceridemia, exacerbation of 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. Consider whether the benefits of estrogen therapy outweigh the risks in women with these conditions. Use with caution in women with past history of cholestatic jaundice, and in the case of recurrence, discontinue EstroGel. Women on thyroid-replacement therapy may require higher doses of thyroid hormone.

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 common adverse reactions with EstroGel (≥ 5 percent) were breast pain, headache, and flatulence.

REFERENCES: 1. EstroGel 0.06% [package insert]. Herndon, VA: ASCEND Therapeutics US, LLC; 2021.

Please see full Prescribing Information, including Boxed Warnings.