WARNING - ENDOMETRIAL CANCER, CARDIOVASCULAR AND OTHER RISKS
ENDOMETRIAL CANCER
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 [see Warnings and Precautions (5.2)].
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1) and (5.3) and Clinical Studies (14.4 and 14.5)].
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 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].
The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT 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 [see Warnings and Precautions (5.1) and (5.2) and Clinical Studies (14.4)].
The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported 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 and 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 [see Warnings and Precautions (5.3), Use in Specific Populations (8.4) and Clinical Studies (14.5)].
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. 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.
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EVAMIST SUMMARY
Evamist (estradiol transdermal spray)
Evamist (estradiol transdermal spray) is designed to deliver estradiol to the blood circulation following topical application to the skin of a rapidly drying solution from a metered-dose pump. Evamist is a homogeneous solution of 1.7% estradiol USP (active ingredient) in alcohol USP and octisalate USP formulated to provide sustained release of the active ingredient into the systemic circulation.
Evamist (estradiol transdermal spray) is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
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NEWS HIGHLIGHTS
Published Studies Related to Evamist (Estradiol Transdermal)
Steady-state pharmacokinetics following application of a novel transdermal estradiol spray in healthy postmenopausal women. [2009.09]
This study was designed to evaluate the steady-state pharmacokinetics (PK) of estradiol and its metabolites, estrone and estrone sulfate, following application of a novel estradiol transdermal spray to healthy postmenopausal women. Participants were randomly assigned in parallel to receive 1-, 2-, or 3-spray doses (24 participants/dose level) of a 1.7% estradiol metered-dose transdermal spray (1.53 mg/spray) once daily for 14 days...
Low-dose transdermal estradiol induces breast density and heterogeneity changes comparable to those of raloxifene. [2009.07]
The aim of this study was to investigate whether transdermal low-dose estradiol treatment induces changes in mammographic density or heterogeneity compared with raloxifene, whether if these changes relate to changes in bone formation/resorption markers, and whether these findings indicate elevation of breast cancer risk by treatment...
Micro-dose transdermal estradiol for relief of hot flushes in postmenopausal Asian women: a randomized controlled trial. [2009.05.25]
Objectives To compare the effect of micro-dose transdermal estradiol and placebo on the incidence and severity of menopausal symptoms and well-being in postmenopausal Asian women with vasomotor symptoms... Micro-dose estradiol was safe and well tolerated in Asian women.
Effect of microdose transdermal 17beta-estradiol compared with raloxifene in the prevention of bone loss in healthy postmenopausal women: a 2-year, randomized, double-blind trial. [2009.05]
OBJECTIVE: Declining estrogen levels after menopause result in bone loss and increased fracture risk. This study investigated whether transdermal microdose 17beta-estradiol (E2) has efficacy and safety comparable to those of raloxifene, a selective estrogen-receptor modulator approved for the prevention and treatment of postmenopausal osteoporosis... CONCLUSIONS: Transdermal microdose E2 was similarly effective as raloxifene in preventing bone loss at the lumbar spine. Both treatments were well tolerated, with no clinically significant effect on endometrium or breast density.
Effect of raloxifene and low-dose percutaneous 17beta-estradiol on menopause symptoms and endometrium-A randomized controlled trial. [2009.01.20]
OBJECTIVE: To investigate the effects on climacteric symptoms and endometrium of percutaneous low-dose 17beta-estradiol associated with raloxifene in postmenopausal women... CONCLUSIONS: The association of percutaneous low dose of 17beta-estradiol with raloxifene exerted favorable effects on hot flushes severity of postmenopausal women, providing a safe profile in endometrium at least in short-term therapy.
Clinical Trials Related to Evamist (Estradiol Transdermal)
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen [Recruiting]
The purpose of this study is to see if Vagifem® is safe for women who have had breast
cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the
vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not
to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a
new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the
vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise
in your estrogen level. However, there is no clear evidence that this would cause any bad
effects in patients with breast cancer. How much, if any, of these topical estrogens are
absorbed through the vagina is not known. We also do not know what the impact is of low
dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as
the mucus membranes are restored after estrogen exposure.
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients [Recruiting]
The purpose of this clinical research study is to determine whether the ESTRING or a special
preparation of a testosterone cream inserted vaginally are safe for use in breast cancer
patients. This study will also evaluate if either of these treatments can improve symptoms
of vaginal dryness or decreased sexual interest that are related to your treatment for
breast cancer.
Initiating Transdermal Estradiol Therapy in Turner's Syndrome [Recruiting]
This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses
of estradiol administered by recently available transdermal patches for the initiation of
puberty in Turner syndrome girls 11. 5-13. 0 years old in conjunction with growth hormone (GH)
therapy.
The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment,
low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating
feminization, height velocity, and bone mineral density without compromising growth
potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior
to GH alone in effects on feminization, height velocity, and bone mineral density.
Postpartum Depression: Transdermal Estradiol Versus Sertraline [Recruiting]
The purpose of this study is to determine whether estrogen patches are effective for the
treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.
A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC [Not yet recruiting]
We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the
number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel
intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo.
The objective of this study is to compare the total number of days of bleeding experienced
by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared
to those randomized to placebo for the first 12 weeks of use. We will enroll women
initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo.
We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for
16 weeks which will be used to calculate the total number of bleeding or spotting days.
Statistical analysis will be performed to evaluate if there is less bleeding among the
treatment arms then the placebo arm.
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Page last updated: 2009-10-20
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