NCT00238732CompletedPhase 3
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
Wyeth is now a wholly owned subsidiary of Pfizer63 sites in 1 country650 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 650
- Locations
- 63
- Primary Endpoint
- Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Study Overview
Brief Summary
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 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.
Investigators
Study Sites (63)
Loading locations...
Similar Trials
Completed
Phase 3
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal WomenEndometrial HyperplasiaOsteoporosisNCT00242710Pfizer1,083
Completed
Phase 3
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal WomenEndometrial HyperplasiaOsteoporosisNCT00675688Wyeth is now a wholly owned subsidiary of Pfizer3,544
Completed
Phase 3
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With MenopauseVasomotor Symptoms Associated With MenopauseNCT00234819Wyeth is now a wholly owned subsidiary of Pfizer325
Completed
Phase 4
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)ObesityGlucose HomeostasisPostmenopausal SymptomsNCT02237079Tulane University Health Sciences Center17
Completed
Phase 1
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal WomenMenopauseNCT00396799Wyeth is now a wholly owned subsidiary of Pfizer