Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Intervention(s) in this Clinical Trial
- Drug: Bazedoxifene/Conjugated Estrogen
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00238732
