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

NCT00314964 | Completed Phase 2

• 1 other identifier: A4291023
• Study Type: interventional
• Target: 527
• Locations: 6 countries
• Sites: 80

Brief Summary

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.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

PD-0299685 DRUG

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (80)

Pfizer Investigational Site

Phoenix, Arizona, 85015, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85741, United States

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Jonesboro, Arkansas, 72401, United States

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Greenbrae, California, 94904, United States

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San Diego, California, 92103, United States

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San Diego, California, 92128, United States

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New London, Connecticut, 06320, United States

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Leesburg, Florida, 34748, United States

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Longwood, Florida, 32779, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33614, United States

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West Palm Beach, Florida, 33407, United States

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Alanta, Georgia, 30342, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30034, United States

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Stockbridge, Georgia, 30281, United States

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Chicago, Illinois, 60610, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46227, United States

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Indianapolis, Indiana, 46280, United States

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Baltimore, Maryland, 21211, United States

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North Dartmouth, Massachusetts, 02747, United States

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Chaska, Minnesota, 55318, United States

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Waconia, Minnesota, 55387, United States

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Olive Branch, Mississippi, 38654, United States

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Springfeild, Missouri, 65807, United States

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Springfeild, Missouri, 65810, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131, United States

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Lebanon, New Hampshire, 03756, United States

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Lawrenceville, New Jersey, 08648, United States

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New Brunswick, New Jersey, 08901, United States

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New Bern, North Carolina, 28562, United States

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Raleigh, North Carolina, 27609, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Sellersville, Pennsylvania, 18960, United States

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Columbia, South Carolina, 29201, United States

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Austin, Texas, 78705, United States

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San Antonio, Texas, 78212, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Arlington, Virginia, 22205, United States

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Richmond, Virginia, 23226, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23455, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99207, United States

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Randwick, New South Wales, 2031, Australia

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Dulwich, South Australia, 5065, Australia

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Clayton, Victoria, 3168, Australia

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Subiaco, Western Australia, 6008, Australia

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Winnipeg, Manitoba, R3T 2E8, Canada

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Burlington, Ontario, L7R 4B8, Canada

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Toronto, Ontario, M5G 1N8, Canada

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Montreal, Quebec, H1T 1P6, Canada

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Québec, Quebec, G1S 2L6, Canada

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Montpellier, Cedex 5, 34094, France

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Évry, 91000, France

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Nantes, 44035, France

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Paris, 75015, France

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Central, Port Elizabeth, Eastern Cape, 6001, South Africa

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Johannesburg, Gauteng, 1829, South Africa

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Midrand, Gauteng, 1685, South Africa

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Radiokop, Gauteng, 1724, South Africa

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Dundee, KwaZulu-Natal, 3000, South Africa

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Westville, KwaZulu-Natal, 3629, South Africa

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Parow, Western Cape, 7550, South Africa

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Gavà, Barcelona, 08850, Spain

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Madrid, Madrid, 28009, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Valencia, Valencia, 46009, Spain

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: August 1, 2006
• Study Completion: July 1, 2007
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

CA (5); ES (4); FR (4); ZA (7); AU (4); US (56)