From the FDA Drug Label
DOSAGE AND ADMINISTRATION ... 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.
Patients should be started at the lowest dose for the indication
The recommended dosing for Vagifem (estradiol) is not explicitly stated in the provided drug label for treating moderate to severe dyspareunia due to menopause. However, for treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, the usual dosage is 10 to 20 mg every four weeks.
- The lowest effective dose has not been determined for any indication.
- Patients should be started at the lowest dose for the indication.
- Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals 1.
From the Research
The recommended dosing for Vagifem (estradiol) for treating moderate to severe dyspareunia due to menopause is 10 mcg inserted vaginally once daily for 2 weeks, followed by a maintenance dose of 10 mcg inserted twice weekly. This dosing regimen is based on the most recent and highest quality study available, which evaluated the safety and efficacy of estradiol vaginal cream 0.003% in postmenopausal women with dyspareunia as the most bothersome symptom 2. The study found that estradiol reduced dyspareunia severity, decreased vaginal pH, and improved vaginal cytology compared to placebo. Vagifem comes as a vaginal tablet with an applicator for insertion, and treatment should be initiated at the lowest effective dose and for the shortest duration consistent with treatment goals. Patients should be reevaluated periodically to determine if treatment is still necessary. Vagifem works by providing low-dose estrogen directly to vaginal tissues, which helps restore vaginal thickness, elasticity, and lubrication without significant systemic absorption. This localized approach helps relieve dyspareunia by addressing the underlying vaginal atrophy that occurs due to estrogen deficiency during menopause. Some studies have also shown that very low-dose estradiol vaginal cream (0.003%) dosed twice weekly is an effective and well-tolerated treatment for VVA symptoms and dryness associated with menopause 3. However, the most recent and highest quality study supports the use of Vagifem at a dose of 10 mcg inserted vaginally once daily for 2 weeks, followed by a maintenance dose of 10 mcg inserted twice weekly. It is essential to note that patients should insert the tablet at approximately the same time each day during initial therapy and on a consistent schedule during maintenance therapy for optimal results. Additionally, women should be informed of the potential benefits and risks of the treatment options available, and with the help of their healthcare provider, choose an intervention that is most suitable to their individual needs and circumstances 4.
Key points to consider:
- Vagifem is a low-dose estrogen therapy that provides targeted efficacy for urogenital tissues with minimal systemic absorption.
- The recommended dosing regimen is 10 mcg inserted vaginally once daily for 2 weeks, followed by a maintenance dose of 10 mcg inserted twice weekly.
- Treatment should be initiated at the lowest effective dose and for the shortest duration consistent with treatment goals.
- Patients should be reevaluated periodically to determine if treatment is still necessary.
- Vagifem works by restoring vaginal thickness, elasticity, and lubrication without significant systemic absorption. The most recent and highest quality study supports the use of Vagifem at the recommended dose, and patients should be informed of the potential benefits and risks of the treatment options available 2, 3, 4.