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Estradiol 0.01% Vag Cream
Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and genitourinary syndrome of menopause.
Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and genitourinary syndrome of menopause. Used for Vaginal atrophy associated with menopause, Genitourinary syndrome of menopause (GSM).
At a glance
| Generic name | Estradiol 0.01% Vag Cream |
|---|---|
| Also known as | Estrace cream |
| Sponsor | TriHealth Inc. |
| Drug class | Estrogen receptor agonist |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Women's Health |
| Phase | FDA-approved |
Mechanism of action
Estradiol is a bioidentical estrogen that acts as an agonist at estrogen receptors (ERα and ERβ) in the vaginal epithelium and urogenital tissues. Local vaginal application delivers high concentrations of estradiol directly to affected tissues while minimizing systemic absorption, thereby restoring vaginal moisture, elasticity, and pH balance without significant systemic hormonal effects.
Approved indications
- Vaginal atrophy associated with menopause
- Genitourinary syndrome of menopause (GSM)
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:
- Estradiol 0.01% Vag Cream CI brief — competitive landscape report
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- TriHealth Inc. portfolio CI