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Premarin Vaginal

Phase 1

Atrophic Vaginitis | Small molecule | Endocrine |Pfizer, Inc.|Trials Updated: May 28, 2007

Premarin Vaginal target and mechanism

ModalitySmall molecule

Also known as Premarin® Vaginal Cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Premarin Vaginal clinical trials

Premarin Vaginal · 1 trial · 1 indication

Phase 1 1
NCT00167921Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic VaginitisAtrophic Vaginitis
COMPLETED24 Analytics
PHASE1COMPLETED
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
Atrophic VaginitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis.

Secondary Endpoints

To estimate the systemic exposure in postmenopausal women taking a typical regimen.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Interventions

NameTypeDescription
Premarin® Vaginal CreamDRUG -
Premarin® oral tabletsDRUG -
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Eligibility Criteria

Age Range45 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Generally healthy postmenopausal women. * Intact uterus. * Clinical diagnosis of moderate to severe atrophic vaginitis.

Countries:United States
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Frequently asked questions about Premarin Vaginal

What is Premarin Vaginal used for?

Premarin Vaginal is used for atrophic vaginitis, a condition in which the vaginal lining thins and dries, often after menopause. It is a small molecule therapy in the endocrine therapeutic area. It was studied in a Phase 1 trial comparing the vaginal cream with oral Premarin tablets in women with atrophic vaginitis.

Who makes Premarin Vaginal?

Premarin Vaginal is made by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the developer of the product, and the clinical program for atrophic vaginitis was sponsored under that company.

What phase is Premarin Vaginal in?

Premarin Vaginal is in Phase 1 development for atrophic vaginitis. The single registered trial, NCT00167921, was a Phase 1 study that has been completed. No active trials are currently listed for this asset, and the completed study enrolled 24 participants.

What clinical trials is Premarin Vaginal in?

Premarin Vaginal has been studied in one clinical trial, NCT00167921, titled Study Comparing Premarin Vaginal Cream Versus Premarin Oral Tablets in Atrophic Vaginitis. The trial was a completed Phase 1 study conducted in the United States with 24 enrolled female participants aged 45 years and older.

Is Premarin Vaginal the same as Premarin Vaginal Cream?

Yes, Premarin Vaginal is also known as Premarin Vaginal Cream. The two names refer to the same product developed by Pfizer for atrophic vaginitis. The Phase 1 trial NCT00167921 compared the vaginal cream formulation with Premarin oral tablets in women with atrophic vaginitis.