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

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.

Completed

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Key information

Conditions

Vasomotor Symptoms Associated With Menopause

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bazedoxifene/Conjugated Estrogen

Drug

Primary outcomes

Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2007
First posted: Oct 7, 2005
Registry last updated: Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed