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

This study has been completed.

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

Sponsored by:	Wyeth
Information provided by:	Wyeth
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:	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.

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by Wyeth:

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Hormone Antagonists

Vaginitis
Hormones, Hormone Substitutes, and Hormone Antagonists
Vaginal Diseases
Atrophy
Hormones

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs
Vaginitis

Hormones, Hormone Substitutes, and Hormone Antagonists
Vaginal Diseases
Atrophy
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009