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

Vasomotor Symptoms Associated With Menopause Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234819
• Other study ID #: 3115A1-305
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2005
• Last updated: December 19, 2007
• Start date: October 2005
• Est. completion date: February 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 Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 64 Years

Eligibility

Inclusion Criteria:

• Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago

• Intact uterus

• Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria:

• History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders

• History of active presence of stroke, TIA, heart attack or ischemic heart disease

• History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Study Design

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

Related Conditions & MeSH terms

• Vasomotor Symptoms Associated With Menopause

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	Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Secondary	Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.