Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

March 14, 2011 updated by: Pfizer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause

The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

527

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • South Australia
      • Dulwich, South Australia, Australia, 5065
        • Pfizer Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Pfizer Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Pfizer Investigational Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2E8
        • Pfizer Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7R 4B8
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 1N8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1P6
        • Pfizer Investigational Site
      • Québec, Quebec, Canada, G1S 2L6
        • Pfizer Investigational Site
  • France
      • Evry, France, 91000
        • Pfizer Investigational Site
      • Nantes, France, 44035
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
    • Cedex 5
      • Montpellier, Cedex 5, France, 34094
        • Pfizer Investigational Site
  • South Africa
    • Eastern Cape
      • Central, Port Elizabeth, Eastern Cape, South Africa, 6001
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Pfizer Investigational Site
      • Midrand, Gauteng, South Africa, 1685
        • Pfizer Investigational Site
      • Radiokop, Gauteng, South Africa, 1724
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Dundee, Kwa-Zulu Natal, South Africa, 3000
        • Pfizer Investigational Site
      • Westville, Kwa-Zulu Natal, South Africa, 3629
        • Pfizer Investigational Site
    • Western Cape
      • Parow, Western Cape, South Africa, 7550
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28009
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Pfizer Investigational Site
    • Barcelona
      • Gava, Barcelona, Spain, 08850
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85015
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85704
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
    • California
      • Greenbrae, California, United States, 94904
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Pfizer Investigational Site
    • Florida
      • Leesburg, Florida, United States, 34748
        • Pfizer Investigational Site
      • Longwood, Florida, United States, 32779
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Georgia
      • Alanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Alpharetta, Georgia, United States, 30005
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30034
        • Pfizer Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46227
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46280
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
      • Waconia, Minnesota, United States, 55387
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Missouri
      • Springfeild, Missouri, United States, 65807
        • Pfizer Investigational Site
      • Springfeild, Missouri, United States, 65810
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78258
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78212
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23229
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23226
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels >40mlU/ml and estradiol < than = 25 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy and FSH levels > 40 mlU/ml and estradiol < than = 25 pg/mL
  • Women reporting at least 50 moderate to severe vasomotor symptoms per week, recorded for seven consecutive days
  • Aged 40 to 70 years

Exclusion Criteria:

  • No estrogen monotherapy or estrogen/progesterone containing drug products within applicable wash out period prior to screening
  • Use of SERMs, clonidine within 4 weeks of screening
  • Use of CNS active medication within 1 week of screening
  • Use of medications (SSRI; SNRI), herbal or dietary supplements, including black cohosh, soy, phytoestrogens or over the counter agent known to possibly be effective for the treatment of vasomotor symptoms, within 4 weeks of screening
  • Participation in clinical trial within 30 days
  • Significant medical or psychiatric illness within past 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.

Secondary Outcome Measures

Outcome Measure
To assess the safety profile of PD-0299685; the benefit of PD-0299685 in quality of life measures and treatment satisfaction of PD-0299685, when compared with placebo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 14, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4291023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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