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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
527

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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