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NCT00167921 Clinical Trial

Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

Atrophic Vaginitis Clinical Trial

Official title:
A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00167921
Other study ID # 0713S5-414
Secondary ID
Status Completed
Phase Phase 1
First received September 9, 2005
Last updated May 25, 2007
Start date October 2005

Study information
Verified date May 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- Generally healthy postmenopausal women.

- Intact uterus.

- Clinical diagnosis of moderate to severe atrophic vaginitis.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin® Vaginal Cream

• Premarin® oral tablets

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To estimate the systemic exposure in postmenopausal women taking a typical regimen.
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