Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

This study has been completed.

First Received: October 12, 2005 Last Updated: December 19, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00238732

Purpose

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Condition	Intervention	Phase
Vaginal Atrophy	Drug: Bazedoxifene/Conjugated Estrogen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated Bazedoxifene

Further study details as provided by Wyeth:

Primary Outcome Measures:

Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Secondary Outcome Measures:

Vaginal pH at screening, and weeks 4 and 12.
Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
Thrombophlebitis, thrombosis or thromboembolic disorders
Neuro-ocular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238732

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3115A1-306
Study First Received:	October 12, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00238732 History of Changes
Health Authority:	United States: Food and Drug Administration; Brazil: National Committee of Ethics in Research

Keywords provided by Wyeth:

Vaginal Atrophy
Postmenopause

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs

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

ClinicalTrials.gov processed this record on March 18, 2010