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”

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

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Bazedoxifene/Conjugated Estrogen

Primary 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 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.

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on March 16, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238732

Study ID Number: 3115A1-306

ClinicalTrials.gov Identifier: NCT00238732

Health Authority: United States: Food and Drug Administration