Important Risk Information
Prescribing Information
Patient Information
For Patients

Talking About Symptoms

Talking About Symptoms

When you talk with your patients about their menopausal symptoms, what’s going unsaid?

While 73% to 75% of postmenopausal women experience symptoms of VVA, only 25% of those women seek treatment.

In the US, vasomotor symptoms (VMS) are among the main menopausal symptoms for which women seek treatment.1,2 In contrast, although nearly 75% of postmenopausal women experience symptoms of vulvar and vaginal atrophy (VVA), only 25% of those women seek treatment.3

While 73% to 75% of postmenopausal women experience symptoms of VVA, only 25% of those women seek treatment.

Only about half of all postmenopausal women speak at all about their vaginal symptoms with their healthcare provider (HCP). In 5 surveys (4 in the US, 1 in Europe), few participants (10%-15%) indicated that their HCP broached the topic of VVA, but many (31%-65%) would prefer that their HCP be the one to start the conversation.4

Although 31% to 65% prefer that HCPs broach the topic of VVA, only 10% to 15% had an HCP who initiated the conversation.

Taking Down Barriers

Patients may not offer information about symptoms until they are asked—particularly when dealing with vaginal health. Nearly a third (32%) of women in the United States who were prescribed treatment for symptoms of VVA had waited at least 1 year after symptoms began; 11% waited at least 3 years.5

That’s a year or more experiencing VVA symptoms without speaking up, perhaps only for lack of a question from an HCP or awareness that relief was a possibility.5

Why aren’t women talking about VVA?4

  • Reluctant to talk about vaginal problems with their HCP
  • Concerned about safety of hormonal treatments
  • Unaware that VVA is related to menopause
  • Believe they must live with VVA as part of aging
  • Unaware that treatments are available

Start the conversation to help your patients become aware of and informed about their options. This technique may help patients to feel more comfortable talking about their symptoms5,6:

  • To inform and provide context, lead with a general statement.

    “After menopause, many women experience vaginal dryness, itching, or pain during sex.”

  • Then offer a simple yes/no question.

    "Have you had any symptoms like those?"

  • If the patient answers in the affirmative, move on to open-ended questions.

    “Tell me more about your experience with these symptoms.”

VVA Symptoms

Moderate to severe symptoms of VVA due to menopause may include7

  • Vaginal dryness
  • Vaginal and/or vulvar irritation/itching
  • Dyspareunia (vaginal pain associated with sexual activity)

Vasomotor Symptoms

VMS, including hot flashes and night sweats, are the menopausal symptoms most commonly reported to healthcare providers.1,2 During and after the transition to menopause, up to 80% of women experience moderate to severe VMS.8

Up to 80% experience VMS.
The median total duration of vasomotor symptoms is approximately 7.4 years in women with frequent VMS.

VMS may last for years. Among all women with frequent VMS, the median total duration of VMS is approximately 7.4 years, with moderate to severe hot flashes persisting a median of about 4.5 years after the last menstrual period.1,8

Duration of menopausal VMS varies greatly by race/ethnicity, with African American women experiencing VMS for the longest (a median total duration of 10.1 years).1

The median total duration of vasomotor symptoms is approximately 7.4 years in women with frequent VMS.

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References: 1. Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015;175(4):531-539. 2. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Fehnel SE, Clark RV. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas. 2007;58(4):348-358. 3. Naumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. Int J Womens Health. 2018;10:387-395. 4. Krychman M, Graham S, Bernick B, Mirkin S, Kingsberg SA. The women's EMPOWER survey: women's knowledge and awareness of treatment options for vulvar and vaginal atrophy remains inadequate. J Sex Med. 2017;14(3):425-433. 5. Parish SJ, Nappi RE, Krychman ML, et al. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health. 2013;5:437-447. 6. Freedman MA. Perceptions of dyspareunia in postmenopausal women with vulvar and vaginal atrophy: findings from the REVIVE survey. Womens Health (Lond). 2014;10(4):445-454. 7. 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. 8. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014;21(9):924-932.

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.