Not Signed In -
Estradiol Vaginal Tablets |
Vagifem |
Clinical Trial: Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
This study is not yet open for patient recruitment.
Verified by Wyeth September 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Atrophic Vaginitis | Drug: Premarin® Vaginal Cream Drug: Premarin® oral tablets | Phase I |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Official Title: A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women with Atrophic Vaginitis.
Further Study Details:
Primary Outcomes: 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 Outcomes: To estimate the systemic exposure in postmenopausal women taking a typical regimen.
Expected Total Enrollment: 24
Secondary Outcomes: To estimate the systemic exposure in postmenopausal women taking a typical regimen.
Expected Total Enrollment: 24
Study start: October 2005
Eligibility
Ages Eligible for Study: 45 Years - 80 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Generally healthy postmenopausal women.
- Intact uterus.
- Clinical diagnosis of moderate to severe atrophic vaginitis.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00167921
Trial Manager clinicaltrialinfo@wyeth.com
Florida
Miami, Florida, 33136, United States
see Central Contact
Maryland
Baltimore, Maryland, 21225, United States
see Central Contact
Study chairs or principal investigators
Medical Monitor, Study Director, Wyeth Research
More Information
Study ID Numbers: 0713S5-414
Last Updated: September 13, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00167921
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20
Last Updated: September 13, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00167921
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20
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