Estradiol transdermal
VIVELLE-DOT
Pronunciation: es-tra-DYE-oel (vye-VEL-dot)
“Es-trojan horse”
What it isER-alpha, ER-beta and GPER agonist delivered through skin; menopausal vasomotor-symptom treatment.
Why this oneCompared with oral estrogen, transdermal delivery has less hepatic effect on clotting and triglycerides and avoids first-pass metabolism.
What limits itWith an intact uterus, add progestogen to prevent endometrial cancer. Breast and thrombotic risks still require screening.
Estradiol transdermal prescription history
Animated chart of estimated U.S. prescriptions per year, Menopausal hormones (1941–2026). Estradiol transdermal enters in 1986 (estimated).
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityVenous thromboembolism and hormone-related adverse effects; estrogen also lowers lamotrigine exposure.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate to severe vasomotor symptoms due to menopause | Postmenopausal women | 0.0375 mg/day patch twice weekly | Adjust to clinical response; try taper/discontinue at 3–6-month intervals | Undefined |
| Moderate to severe vulvar and vaginal atrophy due to menopause | Postmenopausal women | 0.0375 mg/day patch twice weekly | Adjust to clinical response; try taper/discontinue at 3–6-month intervals | Undefined |
| Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure | Women | Not stated on label (section 2.3 blank); patch twice weekly | Adjust to clinical response (lab parameters may guide dosage) | Undefined |
| Prevention of postmenopausal osteoporosis | Postmenopausal women at significant risk of osteoporosis | 0.025 mg/day patch twice weekly | Lowest effective dose | Undefined |
Renal Undefined
Hepatic Contraindicated in hepatic impairment or disease
Twice-weekly system; identical mg/day on a once-weekly product does not mean the same wear interval
Instructions
- Replace the system twice weekly
- Apply to clean, dry trunk skin (abdomen or buttocks), not oily/damaged/irritated; avoid waistline; never on breasts
- Rotate sites, at least 1 week between applications to the same site; press firmly with palm about 10 seconds
- If a system falls off, reapply it or apply a new one elsewhere; keep the original schedule. If forgotten, apply a new system as soon as possible
- Start at once if not on oral estrogen or switching from another transdermal estradiol; if on oral estrogen, start 1 week after stopping it (sooner if symptoms return)
- Woman with a uterus: add a progestogen to reduce endometrial cancer risk; may use cyclic schedule (e.g., 3 weeks on, 1 week off). No uterus: give continuously
- Use lowest effective dose for shortest duration; reevaluate periodically
Available strengths
- patch 0.014, 0.025, 0.0375, 0.05, 0.06, 0.075, 0.1 mg/24 hr
- tab 10 mcg
- tab 0.5, 1, 2 mg
- cream 0.01 %
- gel 0.06, 0.1 %
- insert 4, 10 mcg
- insert 0.0075, 0.05, 0.1 mg/24 hr
- ring 0.05, 0.1 mg/d
- + 2 other marketed forms not shown
Contraindications
- Undiagnosed abnormal genital bleeding
- Breast cancer or history of breast cancer
- Estrogen-dependent neoplasia
- Active DVT, PE, or history of these
- Active arterial thromboembolic disease (e.g., stroke, MI) or history of these
- Known anaphylactic reaction or angioedema with Vivelle-Dot
- Hepatic impairment or disease
- Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Cautions
- Cardiovascular disorders (stroke, CHD, VTE)
- Malignant neoplasms (endometrial, breast, ovarian cancer)
- Probable dementia
- Gallbladder disease
- Hypercalcemia
- Visual abnormalities (retinal vascular thrombosis)
- Add a progestogen if no hysterectomy
- Elevated blood pressure
- Exacerbation of hypertriglyceridemia (pancreatitis)
- Hepatic impairment / past cholestatic jaundice
- Exacerbation of hypothyroidism
- Fluid retention
- Hypocalcemia
- Exacerbation of endometriosis
- Severe anaphylactic/anaphylactoid reactions and angioedema
- Exacerbation of other conditions (asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas)
Adverse reactions
- Headache
- Breast tenderness
- Nasopharyngitis
- Sinusitis
- Sinus headache
- Upper respiratory tract infection
- Back pain
- Depression
- Irregular vaginal bleeding or spotting
Pregnancy Not indicated for use in pregnancy; no data with Vivelle-Dot, but studies of early-pregnancy exposure to combined hormonal contraceptives have not found increased birth-defect risk.
Lactation Estrogens are present in human milk and can reduce milk production; weigh breastfeeding benefits against maternal need.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 0.014 mg/24 hr | patch | per unit | — | $38.74/ea | not offered |
| 0.025 mg/24 hr | patch | per unit | $7.76/ea | — | offered |
| 0.0375 mg/24 hr | patch | per unit | $8.26/ea | — | offered |
| 0.05 mg/24 hr | patch | per unit | $8.50/ea | — | offered |
| 0.06 mg/24 hr | patch | per unit | $12.25/ea | — | offered |
| 0.075 mg/24 hr | patch | per unit | $8.11/ea | — | offered |
| 0.1 mg/24 hr | patch | per unit | $8.57/ea | — | offered |
Other forms: Estradiol (ESTRACE) · Estradiol vaginal (ESTRACE CREAM)
Available combined with: Norelgestromin (in XULANE patch) · drospirenone / ethinyl / estradiol · ethinyl / estradiol / etonogestrel · ethinyl / estradiol / levonorgestrel · ethinyl / estradiol / norethindrone · ethinyl / estradiol / norgestimate
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Memory aids: interaction avatars
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Self-check
- How does transdermal estradiol affect hepatic clotting stimulation versus oral estrogen?
Less stimulation. - Why add a progestogen with an intact uterus?
Prevent endometrial cancer.