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Premarin Vaginal

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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 involving thinning and inflammation of the vaginal walls due to decreased estrogen. It is an investigational small molecule being developed by Pfizer, Inc. for this indication.

What does Premarin Vaginal target?

Premarin Vaginal contains conjugated estrogens, which work by replacing declining estrogen levels in the body. This helps restore the vaginal tissue and relieve symptoms of atrophic vaginitis.

Who makes Premarin Vaginal?

Premarin Vaginal is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.

What phase is Premarin Vaginal in?

Premarin Vaginal is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is Premarin Vaginal in?

Premarin Vaginal has one completed clinical trial, NCT00167921, which compared Premarin Vaginal Cream versus Premarin Oral Tablets in atrophic vaginitis. The trial enrolled 24 female participants aged 45 years and older in the United States.

Is Premarin Vaginal the same as Premarin?

Premarin Vaginal is a specific vaginal cream formulation of Premarin, which is a brand name for conjugated estrogens. While both contain the same active ingredient, Premarin Vaginal is designed for local application to treat atrophic vaginitis.