Hot FlashesPhase 2NCT00314964
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
A Phase 2 study testing PD-0299685 in people with Hot Flashes, run by Pfizer at 80 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- PD-0299685
- How many people
- 527 participants
- Where
- 80 sitesin 6 countries
- Study dates
- Aug 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
80 sites in 6 countries.
80 sites in 6 countries
United States56 sites
Pfizer Investigational Site
Alanta, Georgia, 30342
Pfizer Investigational Site
Alpharetta, Georgia, 30005
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21211
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Decatur, Georgia, 30034
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Indianapolis, Indiana, 46227
Pfizer Investigational Site
Indianapolis, Indiana, 46280
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Lawrenceville, New Jersey, 08648
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Leesburg, Florida, 34748
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Longwood, Florida, 32779
Pfizer Investigational Site
New Bern, North Carolina, 28562
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Phoenix, Arizona, 85015
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Richmond, Virginia, 23226
Pfizer Investigational Site
Richmond, Virginia, 23229
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Antonio, Texas, 78212
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
Springfeild, Missouri, 65807
Pfizer Investigational Site
Springfeild, Missouri, 65810
Pfizer Investigational Site
Stockbridge, Georgia, 30281
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Tucson, Arizona, 85704
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Waconia, Minnesota, 55387
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
South Africa7 sites
Pfizer Investigational Site
Central, Port Elizabeth, Eastern Cape, 6001
Pfizer Investigational Site
Dundee, KwaZulu-Natal, 3000
Pfizer Investigational Site
Johannesburg, Gauteng, 1829
Pfizer Investigational Site
Midrand, Gauteng, 1685
Pfizer Investigational Site
Parow, Western Cape, 7550
Pfizer Investigational Site
Radiokop, Gauteng, 1724
Pfizer Investigational Site
Westville, KwaZulu-Natal, 3629
Canada5 sites
Pfizer Investigational Site
Burlington, Ontario, L7R 4B8
Pfizer Investigational Site
Montreal, Quebec, H1T 1P6
Pfizer Investigational Site
Québec, Quebec, G1S 2L6
Pfizer Investigational Site
Toronto, Ontario, M5G 1N8
Pfizer Investigational Site
Winnipeg, Manitoba, R3T 2E8
Australia4 sites
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Dulwich, South Australia, 5065
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
Subiaco, Western Australia, 6008
France4 sites
Pfizer Investigational Site
Évry, 91000
Pfizer Investigational Site
Montpellier, Cedex 5, 34094
Pfizer Investigational Site
Nantes, 44035
Pfizer Investigational Site
Paris, 75015
Spain4 sites
Pfizer Investigational Site
Gavà, Barcelona, 08850
Pfizer Investigational Site
Madrid, Madrid, 28009
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006
Pfizer Investigational Site
Valencia, Valencia, 46009
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
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
- Being tested
- PD-0299685
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-0299685Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startAug 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314964
- Sponsor's protocol ID
- A4291023
- Status last verified
- Mar 2011
- First submitted
- 13 Apr 2006
- Last updated
- 16 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
- ClinicalTrials.gov ID
- NCT00314964
- Acronym / sponsor ID
- A4291023
- Conditions
- Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-0299685 | Drug | – |
Primary outcome
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
80 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-0299685 in people with Hot Flashes, run by Pfizer at 80 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, South Africa, Canada, Australia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2011.