ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. 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. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant Neoplasms, Endometrial Cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular Disorders.)
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age), during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies).
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. 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.
Vivelle-Dot® (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin.
Vivelle-Dot® (estradiol transdermal system) is indicated in:
Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
Treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risks of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Published Studies Related to Vivelle-DOT (Estradiol)
Effects of tibolone or continuous combined oestradiol/norethisterone acetate on
glucose and insulin metabolism. 
insulin metabolism in postmenopausal women... CONCLUSIONS: Tibolone reduces insulin sensitivity. Healthy postmenopausal women
An overview of four studies of a continuous oral contraceptive (levonorgestrel 90
mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual
and premenstrual syndrome (PMS)... CONCLUSIONS: These data, although not consistent, indicate that continuous LNG/EE
Blastocyst-stage versus cleavage-stage embryo transfer in women with high oestradiol concentrations: randomized controlled trial. [2011.12]
This prospective, randomized, controlled trial tested the hypothesis that delaying embryo transfer to the blastocyst stage can increase the probability of clinical pregnancy and live birth in women with high oestradiol concentrations on the day of human chorionic gonadotrophin (HCG) undergoing intracytoplasmic sperm injection using the long protocol...
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.
Clinical Trials Related to Vivelle-DOT (Estradiol)
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
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8
weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the
relief of vasomotor symptoms and who have hypertension.
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 VagifemŽ 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.
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and ClimaraŽ Transdermal System 0.025 mg/Day [Completed]
The primary objective of this study was to compare the adhesive quality of a new formulation
of the Mylan Estradiol Transdermal System with that of ClimaraŽ Transdermal System following
a single system application in 80 healthy postmenopausal female volunteers. As a secondary
objective, primary dermal irritation was assessed after removal of each transdermal system.
Reports of Suspected Vivelle-DOT (Estradiol) Side Effects
Hot Flush (26),
Drug Ineffective (24),
Feeling Abnormal (18),
Wrong Technique in Drug Usage Process (15),
Insomnia (12), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 11 ratings/reviews, Vivelle-DOT has an overall score of 9.09. The effectiveness score is 9.64 and the side effect score is 9.09. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Vivelle-DOT review by 61 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || menopausal symptoms|
|Dosage & duration:|| || 0.0375 mg patch taken twice per week for the period of 2.5 months|
|Other conditions:|| || allergies and ocular hypertension|
|Other drugs taken:|| || Fexofenedine and Xalatan|
|Benefits:|| || I had recently developed hotflashes which were becoming notceably worse. Very shortly after beginning this drug, my hot flashes stopped. I am hoping there are other benefits like preserving the integrity of my body, but it may be too soon to tell. It definitely alleviated the hot flashes, however.|
|Side effects:|| || None that I have noticed, so far.|
|Comments:|| || This drug comes in a very small patch which you change every three to four days. It's worn on the lower abdomen. That's it. You really can't feel it, and don't even know it's there.|
Vivelle-DOT review by 57 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Menopausal|
|Dosage & duration:|| || 0.1 Patch (dosage frequency: 2/week) for the period of 10+ years|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || Relief of menopausal symptoms, including headaches, hot flashes, mood swings, sleep disturbance, and depression. My marriage and job relationships had been suffering from these symptoms after having a hysterectomy due to severe fibroids.|
|Side effects:|| || No negative side effects. Improved skin, more libido, iwere side benefits.|
|Comments:|| || Apply a patch twice a week to abdomen, according to directions, change it after 3 days/4 days|
Vivelle-DOT review by 49 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || surgical menopause|
|Dosage & duration:|| || 1.0 (dosage frequency: twice a week) for the period of 2 months|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || The benefits are that it does take away night sweats and hot flashes.|
|Side effects:|| || The side effect I have noticed is very sore swollen breasts and weight gain! Not sure if I want to stay on the Vivelle Dot for those reasons. The weight gain is making me very unhappy.|
|Comments:|| || Change the patch twice a week.|
Page last updated: 2013-02-10