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Vivelle-DOT (Estradiol) - Summary



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.)


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:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
  4. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk 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.

See all Vivelle-DOT indications & dosage >>


Published Studies Related to Vivelle-DOT (Estradiol)

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing

Effect of estradiol valerate on endometrium thickness during clomiphene citrate-stimulated ovulation. [2014]
CONCLUSIONS: We concluded that the addition of 6 mg/day EV following the CC

[Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 µg in the treatment of premenstrual dysphoric disorder: a randomized, double blind placebo-controlled study]. [Article in Chinese] [2014]
with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD)... CONCLUSIONS: YAZ could improve symptoms of PMDD better than placebo, while

Effects of tibolone or continuous combined oestradiol/norethisterone acetate on glucose and insulin metabolism. [2013]
insulin metabolism in postmenopausal women... CONCLUSIONS: Tibolone reduces insulin sensitivity. Healthy postmenopausal women

Impact of estradiol valerate/dienogest on work productivity and activities of daily living in women with heavy menstrual bleeding. [2013]
estradiol valerate/dienogest (E2V/DNG; Qlaira(®)/Natazia(®)) compared to placebo... CONCLUSIONS: E2V/DNG was shown to have a consistent positive impact on work

more studies >>

Reports of Suspected Vivelle-DOT (Estradiol) Side Effects

Hot Flush (26)Drug Ineffective (24)Feeling Abnormal (18)Nausea (16)Wrong Technique in Drug Usage Process (15)Fatigue (13)Depression (13)Asthenia (13)Malaise (12)Insomnia (12)more >>


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
Treatment Info
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
Reported Results
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
Treatment Info
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
Reported Results
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
Treatment Info
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
Reported Results
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.

See all Vivelle-DOT reviews / ratings >>

Page last updated: 2015-08-10

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