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

This study has been completed.

First Received on September 9, 2005. Last Updated on May 25, 2007 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00167921

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	24
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167921

Locations

United States, Florida

Miami, Florida, United States, 33136
United States, Maryland

Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00167921 History of Changes
Other Study ID Numbers:	0713S5-414
Study First Received:	September 9, 2005
Last Updated:	May 25, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Estrogens, Conjugated (USP)

Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012