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NCT00314964 Clinical Trial

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

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00314964
Other study ID # A4291023
Secondary ID
Status Completed
Phase Phase 2
First received April 13, 2006
Last updated March 14, 2011
Start date August 2006
Est. completion date July 2007

Study information
Verified date March 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 527
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PD-0299685

Locations
Country Name City State
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Dulwich South Australia
Australia Pfizer Investigational Site Randwick New South Wales
Australia Pfizer Investigational Site Subiaco Western Australia
Canada Pfizer Investigational Site Burlington Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Québec Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
France Pfizer Investigational Site Evry
France Pfizer Investigational Site Montpellier Cedex 5
France Pfizer Investigational Site Nantes
France Pfizer Investigational Site Paris
South Africa Pfizer Investigational Site Central, Port Elizabeth Eastern Cape
South Africa Pfizer Investigational Site Dundee Kwa-Zulu Natal
South Africa Pfizer Investigational Site Johannesburg Gauteng
South Africa Pfizer Investigational Site Midrand Gauteng
South Africa Pfizer Investigational Site Parow Western Cape
South Africa Pfizer Investigational Site Radiokop Gauteng
South Africa Pfizer Investigational Site Westville Kwa-Zulu Natal
Spain Pfizer Investigational Site Gava Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Oviedo Asturias
Spain Pfizer Investigational Site Valencia
United States Pfizer Investigational Site Alanta Georgia
United States Pfizer Investigational Site Alpharetta Georgia
United States Pfizer Investigational Site Arlington Virginia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Chaska Minnesota
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Greenbrae California
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Lawrenceville New Jersey
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Leesburg Florida
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Longwood Florida
United States Pfizer Investigational Site New Bern North Carolina
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New London Connecticut
United States Pfizer Investigational Site North Dartmouth Massachusetts
United States Pfizer Investigational Site Olive Branch Mississippi
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Sellersville Pennsylvania
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Springfeild Missouri
United States Pfizer Investigational Site Springfeild Missouri
United States Pfizer Investigational Site Stockbridge Georgia
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Waconia Minnesota
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  South Africa,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
Secondary 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.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04587154 - Womens Study to Alleviate Vasomotor Symptoms N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05061563 - A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults Phase 1
Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
Completed NCT01281332 - Mechanical Device for the Relief of Hot Flashes Phase 2
Completed NCT01439945 - Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer Phase 2
Completed NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Phase 3
Completed NCT01293695 - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00391417 - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms Phase 3
Terminated NCT00244894 - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Recruiting NCT06030388 - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A
Recruiting NCT04861701 - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise N/A
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2

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