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 ].
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 and 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 and Clinical Studies].
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 and and Clinical Studies].
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 Use in Specific Populations and Clinical Studies].
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)
Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. [2011.11.29]
BACKGROUND: This study evaluated the ethinyl estradiol (EE) and levonorgestrel (LNG) pharmacokinetic profiles of AG200-15, a transdermal contraceptive delivery system, compared with a combination oral contraceptive (COC) containing EE 35 mcg and norgestimate 250 mcg... CONCLUSIONS: EE and LNG daily exposure during AG200-15 treatment was within the range reported for a low-dose COC. The daily EE dose with AG 200-15 was equivalent to a 30-mcg COC and was safe and well tolerated. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. [2011.09.24]
OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system... CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo. Copyright A(c) 2011 Mosby, Inc. All rights reserved.
Prevention of menstrual migraine with perimenstrual transdermal 17-beta-estradiol: a randomized, placebo-controlled, double-blind crossover study. [2011.08]
The effect of treatment with percutaneous E(2) (100 mug/24 h) during 2 weeks perimenstrually on the number and severity of menstrual migraine attacks was studied in 27 women in a randomized, placebo-controlled, double-blind, crossover trial. We were not able to demonstrate any difference between E(2) supplementation and placebo on the number or severity of migraine attacks, but both regimens showed significant effects compared with before treatment.
Increased estradiol and improved sleep, but not hot flashes, predict enhanced mood during the menopausal transition. [2011.07]
BACKGROUND: The antidepressant effect of estrogen in women undergoing the menopause transition is hypothesized to be mediated by central nervous system effects of increasing estradiol on mood or through a pathway involving suppression of hot flashes and associated sleep disturbance. Estrogen therapy (ET) and the hypnotic agent zolpidem were selected as interventions in a three-arm, double-blind, placebo-controlled trial to distinguish the effects of estradiol, sleep, and hot flashes on depression... CONCLUSIONS: For women with menopause-associated depression, improvement in depression is predicted by improved sleep, and among perimenopausal women, by increasing estradiol levels. These results suggest that changes in estradiol and sleep quality, rather than hot flashes, mediate depression during the menopause transition. Therapies targeting insomnia may be valuable in treating menopause-associated depression.
[Influence of estradiol administration mode on plasma insulin-like growth factor-I (IGF-I) and its binding proteins 1 and 3 concentration in postmenopausal women treated with norethisterone acetate]. [2011.03]
CONCLUSION: Mode of administration of estradiol did not influenced the plasma levels of IGF-I, IGFBP-1, IGFBP-3 in postmenopausal women treated with norethisterone acetate.
Clinical Trials Related to Evamist (Estradiol Transdermal)
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.
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® 10mcg 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.
Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function [Recruiting]
This study compares the effects of two common hormone medications on the heart and blood
vessels of healthy post-menopausal women over the age of 45.
The study will take place over the course of about 5 months. Each subject will take two
different medications over two six-week periods. They will be randomized at the beginning of
the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the
first period, and will receive the other medication the second six-weeks of the study. At
the very beginning of the study and at the end of each six-week treatment period, subjects
will come to the hospital various tests including non-invasive blood vessel imaging tests,
blood draws to test the levels of certain hormones in the body, an oral glucose tolerance
test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between
treatment periods, there will be a four-week medication-free washout period.
Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms [Recruiting]
The primary objective of this study is to determine the efficacy of both low-dose oral (by
mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in
reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR
to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is
currently considered the most established but also a controversial therapy. 17-ß-estradiol
is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine.
Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a
substance containing no medication.
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.
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Page last updated: 2011-12-09
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