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Estrace 0.01% Vaginal Cream
Estrace 0.01% Vaginal Cream is a Estrogen replacement therapy Small molecule drug developed by University of California, Irvine. It is currently FDA-approved for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.
Estrace vaginal cream delivers estradiol directly to vaginal tissues to restore estrogen levels and relieve symptoms of vaginal atrophy and menopausal urogenital changes.
Estrace vaginal cream delivers estradiol directly to vaginal tissues to restore estrogen levels and relieve symptoms of vaginal atrophy and menopausal urogenital changes. Used for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.
At a glance
| Generic name | Estrace 0.01% Vaginal Cream |
|---|---|
| Sponsor | University of California, Irvine |
| 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 cells, promoting cell proliferation, increasing vaginal blood flow, and restoring normal vaginal pH and lubrication. This local hormone replacement therapy alleviates symptoms such as vaginal dryness, itching, burning, and dyspareunia associated with menopause or estrogen deficiency.
Approved indications
- Vaginal atrophy and urogenital symptoms associated with menopause
- Atrophic vaginitis
Common side effects
- Vaginal irritation or burning
- Headache
- Breast tenderness
- Vaginal discharge
Key clinical trials
- 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)
- Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial (PHASE2, PHASE3)
- Treatment of Prepubertal Labial Adhesions (NA)
- Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome (PHASE4)
- Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy (PHASE3)
- A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis (PHASE3)
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:
- Estrace 0.01% Vaginal Cream CI brief — competitive landscape report
- Estrace 0.01% Vaginal Cream updates RSS · CI watch RSS
- University of California, Irvine portfolio CI
Frequently asked questions about Estrace 0.01% Vaginal Cream
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Related
- Drug class: All Estrogen replacement therapy drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)
- Manufacturer: University of California, Irvine — full pipeline
- Therapeutic area: All drugs in Gynecology / Endocrinology
- Indication: Drugs for Vaginal atrophy and urogenital symptoms associated with menopause
- Indication: Drugs for Atrophic vaginitis
- Compare: Estrace 0.01% Vaginal Cream vs similar drugs
- Pricing: Estrace 0.01% Vaginal Cream cost, discount & access