Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis - Full Text View

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

ChemIDplus related topics:

Estrogens, conjugated

U.S. FDA Resources

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

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

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

Keywords provided by Wyeth:

Postmenopause

Vaginitis

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Genital Diseases, Female

Estrogens, Conjugated (USP)

Vaginitis

Vaginal Diseases

Atrophy

Additional relevant MeSH terms:

Estrogens

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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