Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrophic Vaginitis
Intervention: Premarin® Vaginal Cream (Drug); Premarin® oral tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.
Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
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.
Secondary outcome: To estimate the systemic exposure in postmenopausal women taking a typical regimen.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Generally healthy postmenopausal women.
- Intact uterus.
- Clinical diagnosis of moderate to severe atrophic vaginitis.
Locations and Contacts
Miami, Florida 33136, United States
Baltimore, Maryland 21225, United States
Additional Information
Starting date: October 2005
Last updated: May 25, 2007
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