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Estradiol vaginal cream
Estradiol vaginal cream delivers the hormone estradiol directly to vaginal tissues to restore local estrogen levels and relieve menopausal vaginal symptoms.
Estradiol vaginal cream delivers the hormone estradiol directly to vaginal tissues to restore local estrogen levels and relieve menopausal vaginal symptoms. Used for Atrophic vaginitis and vaginal atrophy associated with menopause, Vaginal dryness and dyspareunia in postmenopausal women.
At a glance
| Generic name | Estradiol vaginal cream |
|---|---|
| Also known as | Estrace, National Drug Code 0430-3754 |
| Sponsor | CONRAD |
| Drug class | Estrogen replacement therapy |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Estradiol is a potent estrogen that binds to estrogen receptors in vaginal epithelial and supporting tissues, promoting cell proliferation, increasing blood flow, and restoring vaginal moisture and elasticity. The vaginal route of administration allows for high local concentrations while minimizing systemic absorption, reducing the risk of systemic hormone exposure compared to oral hormone replacement therapy.
Approved indications
- Atrophic vaginitis and vaginal atrophy associated with menopause
- Vaginal dryness and dyspareunia in postmenopausal women
Common side effects
- Vaginal irritation or burning
- Headache
- Breast tenderness
- Vaginal bleeding or spotting
Key clinical trials
- Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (PHASE2)
- Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause (NA)
- Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery (PHASE4)
- Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections (PHASE4)
- Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause (NA)
- Multidisciplinary Treatment of Chronic Vulvar Pain (NA)
- Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial (PHASE2, PHASE3)
- Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Estradiol vaginal cream CI brief — competitive landscape report
- Estradiol vaginal cream updates RSS · CI watch RSS
- CONRAD portfolio CI