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

NCT ID: NCT00314964

Last Updated: 2011-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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PD-0299685

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Greenbrae, California, United States

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San Diego, California, United States

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San Diego, California, United States

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New London, Connecticut, United States

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Leesburg, Florida, United States

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Longwood, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Alanta, Georgia, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Chaska, Minnesota, United States

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Waconia, Minnesota, United States

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Olive Branch, Mississippi, United States

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Springfeild, Missouri, United States

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Springfeild, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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Lawrenceville, New Jersey, United States

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New Brunswick, New Jersey, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Sellersville, Pennsylvania, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Randwick, New South Wales, Australia

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Dulwich, South Australia, Australia

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Clayton, Victoria, Australia

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Subiaco, Western Australia, Australia

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Winnipeg, Manitoba, Canada

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Burlington, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Montpellier, Cedex 5, France

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Évry, , France

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Nantes, , France

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Paris, , France

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Central, Port Elizabeth, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Midrand, Gauteng, South Africa

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Radiokop, Gauteng, South Africa

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Dundee, KwaZulu-Natal, South Africa

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Westville, KwaZulu-Natal, South Africa

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Parow, Western Cape, South Africa

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Gavà, Barcelona, Spain

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Madrid, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Valencia, Valencia, Spain

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Countries

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United States Australia Canada France South Africa Spain

Related Links

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Other Identifiers

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A4291023

Identifier Type: -

Identifier Source: org_study_id