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Vaginal estradiol tablets
Vaginal estradiol tablets is a Estrogen receptor agonist Small molecule drug developed by Johns Hopkins University. It is currently FDA-approved for Vaginal atrophy due to menopause, Genitourinary syndrome of menopause (GSM).
Vaginal estradiol tablets deliver estrogen directly to vaginal tissue to relieve symptoms of vaginal atrophy and genitourinary syndrome of menopause.
Vaginal estradiol tablets are used to treat conditions such as atrophic vaginitis and menopausal complaints. They work by acting as an estrogen receptor alpha agonist, which is a type of small molecule that binds to estrogen receptors.
At a glance
| Generic name | Vaginal estradiol tablets |
|---|---|
| Sponsor | Johns Hopkins University |
| Drug class | Estrogen receptor agonist |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Gynecology |
| Phase | FDA-approved |
Mechanism of action
Estradiol is a naturally occurring estrogen that binds to estrogen receptors in vaginal epithelial cells, promoting cell proliferation and restoring vaginal maturation and lubrication. The vaginal route of administration provides local therapeutic effect while minimizing systemic absorption compared to oral hormone therapy. This localized delivery helps restore vaginal health and alleviates symptoms such as dryness, irritation, and dyspareunia associated with menopause-related estrogen deficiency.
Approved indications
- Vaginal atrophy due to menopause
- Genitourinary syndrome of menopause (GSM)
Common side effects
- Vaginal irritation or discomfort
- Headache
- Vaginal discharge
- Breast tenderness
Key clinical trials
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Preventing Recurrent UTI With Vaginal Estrogen (PHASE4)
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion (NA)
- Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder (PHASE4)
- REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy (PHASE2)
- Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections (PHASE4)
- Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen (NA)
- 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:
- Vaginal estradiol tablets CI brief — competitive landscape report
- Vaginal estradiol tablets updates RSS · CI watch RSS
- Johns Hopkins University portfolio CI
Frequently asked questions about Vaginal estradiol tablets
What is Vaginal estradiol tablets?
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What is Vaginal estradiol tablets used for?
Who makes Vaginal estradiol tablets?
What drug class is Vaginal estradiol tablets in?
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What does Vaginal estradiol tablets target?
Related
- Drug class: All Estrogen receptor agonist drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)
- Manufacturer: Johns Hopkins University — full pipeline
- Therapeutic area: All drugs in Women's Health / Gynecology
- Indication: Drugs for Vaginal atrophy due to menopause
- Indication: Drugs for Genitourinary syndrome of menopause (GSM)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing