Clinical trial NCT00314964: Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 527
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Leesburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Alanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Alpharetta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Waconia
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Springfeild
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfeild
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Bern
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Dulwich
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Subiaco
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Québec
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 5
city: Evry
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Central, Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Midrand
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Radiokop
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Dundee
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Westville
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Gava
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: