From the FDA Drug Label
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. For treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. The usual dosage is 10 to 20 mg Estradiol Valerate Injection every four weeks
The recommended dose of vaginal estrogen (estrogen replacement therapy) is 10 to 20 mg every four weeks.
- The lowest effective dose should be used for the shortest duration consistent with treatment goals and risks.
- Patients should be started at the lowest dose for the indication and reevaluated periodically as clinically appropriate 1
From the Research
Recommended Dose of Vaginal Estrogen
The recommended dose of vaginal estrogen for the treatment of vaginal atrophy in postmenopausal women is a low dose, as indicated by several studies 2, 3, 4.
- Low-dose vaginal estrogen products approved in the United States for the treatment of vaginal atrophy are equally effective at the doses recommended in labeling 2.
- The choice of therapy should be guided by clinical experience and patient preference 2.
- Low-dose vaginal estrogen, arbitrarily defined as the 7.5-μg vaginal ring and 10-μg tablet, increased plasma estradiol levels during chronic administration but not above the normal range of ≤ 20 pg/ml 3.
- Intermediate doses (i.e. 25 μg estradiol or 0.3 mg conjugated equine estrogen) resulted in plasma estradiol levels approaching or exceeding 20 pg/ml 3.
- Higher doses (50-2000 μg estradiol or 0.625-2.5 mg conjugated equine estrogen) resulted in premenopausal levels of estrogen 3.
Safety and Efficacy
- Low-dose vaginal estrogen appears to be an effective strategy for managing women whose symptoms result from vulvovaginal atrophy, with limited but not completely eliminated systemic absorption 3.
- The use of low-dose vaginal estrogens for treating vulvar and vaginal atrophy in menopausal women does not support an increased risk of endometrial hyperplasia or cancer 4.
- Low-dose estrogen therapy may have a dose-dependent effect on bone density, with some preparations preserving lumbar and femoral bone density 5.
- Breast tenderness and skeletal effects are likely dose-dependent, and low-dose estrogen alone may not protect bone unless adequate calcium is given 5.
Clinical Considerations
- Progestogen is generally not indicated when low-dose estrogen is administered locally for vaginal atrophy 2.
- Data are insufficient to recommend annual endometrial surveillance in asymptomatic women using vaginal estrogen therapy 2.
- Vaginal estrogen therapy should be continued for women as long as distressful symptoms remain 2.