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

Phase 3

Completed

• Conditions: Vaginal Atrophy

• Registration Number: NCT00238732
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Study Completion: 2007-03
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 650

Inclusion Criteria

• Generally healthy, postmenopausal women, aged 40 to 65 years
• Intact uterus
• At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.