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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome: To estimate the systemic exposure in postmenopausal women taking a typical regimen.

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 9, 2005
Date Started: October 2005
Date Completion:
Last Updated: May 25, 2007
Last Verified: May 2007