Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

This study has been completed.

First Received: August 25, 2005 Last Updated: December 7, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00137371

Purpose

This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

Condition	Intervention	Phase
Atrophic Vaginitis Atrophy Vaginitis	Drug: PVC (daily for 21 days, 7 days off) Drug: PVC (twice weekly)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally 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 evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.

Secondary Outcome Measures:

To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.

Estimated Enrollment:	480
Study Start Date:	August 2005
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.

The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.

Exclusion Criteria:

Women who do not have a clinical diagnosis of atrophic vaginitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137371

Show 49 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Principal Investigator:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0713S5-413
Study First Received:	August 25, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00137371 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Postmenopause
Vaginitis

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 February 08, 2010