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Estradiol Vaginal Cream, 0.01%

Mylan Pharmaceuticals Inc · Phase 3 active Small molecule

Estradiol Vaginal Cream, 0.01% is a Estrogen replacement therapy (local/vaginal) Small molecule drug developed by Mylan Pharmaceuticals Inc. It is currently in Phase 3 development for Vaginal atrophy associated with menopause, Genitourinary syndrome of menopause (GSM).

Estradiol vaginal cream delivers the hormone estrogen directly to vaginal tissues to relieve symptoms of vaginal atrophy and genitourinary syndrome of menopause.

Estradiol vaginal cream delivers the hormone estrogen directly to vaginal tissues to relieve 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 nameEstradiol Vaginal Cream, 0.01%
SponsorMylan Pharmaceuticals Inc
Drug classEstrogen replacement therapy (local/vaginal)
TargetEstrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)
ModalitySmall molecule
Therapeutic areaGynecology / Menopause
PhasePhase 3

Mechanism of action

Estradiol is a form of estrogen that binds to estrogen receptors in vaginal epithelial cells, promoting cell proliferation and restoring vaginal tissue thickness, elasticity, and moisture. This local hormone replacement therapy alleviates symptoms such as vaginal dryness, itching, burning, and dyspareunia without requiring systemic absorption.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

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Frequently asked questions about Estradiol Vaginal Cream, 0.01%

What is Estradiol Vaginal Cream, 0.01%?

Estradiol Vaginal Cream, 0.01% is a Estrogen replacement therapy (local/vaginal) drug developed by Mylan Pharmaceuticals Inc, indicated for Vaginal atrophy associated with menopause, Genitourinary syndrome of menopause (GSM).

How does Estradiol Vaginal Cream, 0.01% work?

Estradiol vaginal cream delivers the hormone estrogen directly to vaginal tissues to relieve symptoms of vaginal atrophy and genitourinary syndrome of menopause.

What is Estradiol Vaginal Cream, 0.01% used for?

Estradiol Vaginal Cream, 0.01% is indicated for Vaginal atrophy associated with menopause, Genitourinary syndrome of menopause (GSM).

Who makes Estradiol Vaginal Cream, 0.01%?

Estradiol Vaginal Cream, 0.01% is developed by Mylan Pharmaceuticals Inc (see full Mylan Pharmaceuticals Inc pipeline at /company/mylan-pharmaceuticals-inc).

What drug class is Estradiol Vaginal Cream, 0.01% in?

Estradiol Vaginal Cream, 0.01% belongs to the Estrogen replacement therapy (local/vaginal) class. See all Estrogen replacement therapy (local/vaginal) drugs at /class/estrogen-replacement-therapy-local-vaginal.

What development phase is Estradiol Vaginal Cream, 0.01% in?

Estradiol Vaginal Cream, 0.01% is in Phase 3.

What are the side effects of Estradiol Vaginal Cream, 0.01%?

Common side effects of Estradiol Vaginal Cream, 0.01% include Vaginal irritation or burning, Headache, Breast tenderness, Vaginal bleeding or spotting.

What does Estradiol Vaginal Cream, 0.01% target?

Estradiol Vaginal Cream, 0.01% targets Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) and is a Estrogen replacement therapy (local/vaginal).

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