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Estrace® 0.01% cream
Estrace cream delivers estradiol, a natural estrogen, directly to vaginal and vulvar tissues to relieve symptoms of atrophic vaginitis and urogenital atrophy.
Estrace cream delivers estradiol, a natural estrogen, directly to vaginal and vulvar tissues to relieve symptoms of atrophic vaginitis and urogenital atrophy. Used for Atrophic vaginitis (vaginal atrophy) associated with menopause, Urogenital atrophy symptoms including vaginal dryness and dyspareunia.
At a glance
| Generic name | Estrace® 0.01% cream |
|---|---|
| Sponsor | Mylan Pharmaceuticals Inc |
| Drug class | Estrogen replacement therapy |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Estradiol is a potent estrogen that binds to estrogen receptors in vaginal epithelial cells, restoring tissue thickness, elasticity, and moisture. This localized hormone replacement therapy alleviates vaginal dryness, irritation, and dyspareunia associated with menopause or other causes of estrogen deficiency. The 0.01% cream formulation provides topical delivery with minimal systemic absorption.
Approved indications
- Atrophic vaginitis (vaginal atrophy) associated with menopause
- Urogenital atrophy symptoms including vaginal dryness and dyspareunia
Common side effects
- Vaginal irritation or burning
- Headache
- Breast tenderness
- Vaginal bleeding or spotting
Key clinical trials
- 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)
- A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis (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® 0.01% cream CI brief — competitive landscape report
- Estrace® 0.01% cream updates RSS · CI watch RSS
- Mylan Pharmaceuticals Inc portfolio CI