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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00314964




Registration number
NCT00314964
Ethics application status
Date submitted
13/04/2006
Date registered
17/04/2006
Date last updated
16/03/2011

Titles & IDs
Public title
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
Secondary ID [1] 0 0
A4291023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hot Flashes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PD-0299685

Treatment: Drugs: PD-0299685
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Dulwich
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5065 - Dulwich
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Maryland
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Massachusetts
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Missouri
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Nebraska
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New Hampshire
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New Jersey
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Cedex 5
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France
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Evry
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France
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Nantes
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France
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Paris
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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Kwa-Zulu Natal
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South Africa
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Western Cape
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00314964
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries