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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

May 25, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00167921 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To estimate the systemic exposure in postmenopausal women taking a typical regimen.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study

Condition ^ICMJE

Atrophic Vaginitis

Intervention ^ICMJE

Drug: Premarin® Vaginal Cream
Drug: Premarin® oral tablets

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Generally healthy postmenopausal women.
Intact uterus.
Clinical diagnosis of moderate to severe atrophic vaginitis.

Gender

Female

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00167921

Responsible Party

Study ID Numbers ^ICMJE

0713S5-414

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP