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NCT00238732 Clinical Trial

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

Vaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238732
Other study ID # 3115A1-306
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated December 19, 2007
Start date October 2005
Est. completion date March 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBrazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 650
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Bazedoxifene/Conjugated Estrogen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Primary Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Secondary Vaginal pH at screening, and weeks 4 and 12.
Secondary Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.
See also
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Completed NCT00429806 - DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy Phase 1