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Estrace® Vaginal Cream USP, 0.01%
Estrace® Vaginal Cream USP, 0.01% is a Estrogen replacement therapy (local/vaginal) Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.
Estrace vaginal cream delivers estradiol directly to vaginal tissue to restore estrogen levels and relieve symptoms of vaginal atrophy and urogenital aging.
Estrace vaginal cream delivers estradiol directly to vaginal tissue to restore estrogen levels and relieve symptoms of vaginal atrophy and urogenital aging. Used for Vaginal atrophy and urogenital symptoms associated with menopause, Atrophic vaginitis.
At a glance
| Generic name | Estrace® Vaginal Cream USP, 0.01% |
|---|---|
| Sponsor | Actavis Inc. |
| Drug class | Estrogen replacement therapy (local/vaginal) |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Menopause |
| Phase | Phase 3 |
Mechanism of action
Estradiol is a bioidentical estrogen that binds to estrogen receptors in the vaginal epithelium, promoting cellular proliferation, increasing vaginal blood flow, and restoring vaginal moisture and elasticity. This local hormone replacement therapy alleviates symptoms such as vaginal dryness, dyspareunia, and urinary discomfort 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
- Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy (PHASE3)
- Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in 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® Vaginal Cream USP, 0.01% CI brief — competitive landscape report
- Estrace® Vaginal Cream USP, 0.01% updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Estrace® Vaginal Cream USP, 0.01%
What is Estrace® Vaginal Cream USP, 0.01%?
How does Estrace® Vaginal Cream USP, 0.01% work?
What is Estrace® Vaginal Cream USP, 0.01% used for?
Who makes Estrace® Vaginal Cream USP, 0.01%?
What drug class is Estrace® Vaginal Cream USP, 0.01% in?
What development phase is Estrace® Vaginal Cream USP, 0.01% in?
What are the side effects of Estrace® Vaginal Cream USP, 0.01%?
What does Estrace® Vaginal Cream USP, 0.01% target?
Related
- Drug class: All Estrogen replacement therapy (local/vaginal) drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Gynecology / Menopause
- Indication: Drugs for Vaginal atrophy and urogenital symptoms associated with menopause
- Indication: Drugs for Atrophic vaginitis
- Compare: Estrace® Vaginal Cream USP, 0.01% vs similar drugs
- Pricing: Estrace® Vaginal Cream USP, 0.01% cost, discount & access