Vasomotor SymptomsPhase 3NCT00683800

Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

A Phase 3 study testing desvenlafaxine succinate (DVS) SR in people with Vasomotor Symptoms, run by Pfizer at 121 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women. Read more about this study

Who is it for?: Ages 45 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Vasomotor Symptoms
What is being tested?: desvenlafaxine succinate (DVS) SR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,186 participants
Where: 121 sitesin 2 countries
Study dates: Jun 2008to May 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Generally healthy, postmenopausal women who seek treatment for hot flushes
Body Mass Index (BMI) less than or equal to 34 kg/m^2

Who cannot join

Hypersensitivity to Venlafaxine
Myocardial infarction an/or unstable angina within 6 months of screening
History of seizure disorder

Trial locations and contacts

121 sites in 2 countries.

Country

City, postcode or hospital

121 sites in 2 countries

United States102 sites

Pfizer Investigational Site
Akron, Ohio, 44311
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Billings, Montana, 59102
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Bismarck, North Dakota, 58501
Pfizer Investigational Site
Boise, Idaho, 83702
Pfizer Investigational Site
Brooklyn Center, Minnesota, 55430
Pfizer Investigational Site
Brooksville, Florida, 34601
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0457
Pfizer Investigational Site
Clearwater, Florida, 33759
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Colorado Springs, Colorado, 80910
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Dallas, Texas, 75234
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Decatur, Georgia, 30319
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Englewood, Colorado, 80112
Pfizer Investigational Site
Englewood, Ohio, 45322
Pfizer Investigational Site
Erie, Pennsylvania, 16502
Pfizer Investigational Site
Erie, Pennsylvania, 16507-1411
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fargo, North Dakota, 58104
Pfizer Investigational Site
Fort Myers, Florida, 33916
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Glendale, Arizona, 85308
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hilton Head Island, South Carolina, 29926
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Jamestown, North Dakota, 58401
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Little Rock, Arkansas, 72223
Pfizer Investigational Site
Longmont, Colorado, 80501
Pfizer Investigational Site
Louisville, Kentucky, 40291
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Menomonee Falls, Wisconsin, 53051
Pfizer Investigational Site
Midland, Texas, 79705
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112-4481
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Salt Lake City, Utah, 84117
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
Savannah, Georgia, 31406
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Sioux Falls, South Dakota, 57104
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tucson, Arizona, 85710
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Vista, California, 92083
Pfizer Investigational Site
Waco, Texas, 76712
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Watertown, South Dakota, 57201
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
Wexford, Pennsylvania, 15090
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada19 sites

Pfizer Investigational Site
Antigonish Nova Scotia, Nova Scotia, B2G 2C2
Pfizer Investigational Site
Calgary, Alberta, T2N 4L7
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3V9
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Gatineau, Quebec, J9A 1K7
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
Ottawa, Ontario, K1H 7W9
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Québec, Quebec, G1S 2L6
Pfizer Investigational Site
Saint Romuald, Quebec, G6W 5M6
Pfizer Investigational Site
Saint-Janvier, Quebec, J7J 2K8
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Shawinigan, Quebec, G9N 2H6
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 4J6
Pfizer Investigational Site
Surrey, British Columbia, V4A 2H9
Pfizer Investigational Site
Toronto, Ontario, M4S 1Y2
Pfizer Investigational Site
Toronto, Ontario, M5B 1W8
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Winnipeg, Manitoba, R3T 2E8

Other trials in Canada

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause

Conditions: Vasomotor Symptoms
Being tested: desvenlafaxine succinate (DVS) SR, Placebo
Keywords: Menopause, Hot Flush, Hot Flash, Desvenlafaxine succinate Sustained Release
Medical subject headings: Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

desvenlafaxine succinate (DVS) SRDrug
Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
PlaceboDrug
Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

Study groups in NCT00683800
Study group	Role	What they receive
1	Experimental	desvenlafaxine succinate (DVS) SR Receives: Drug: desvenlafaxine succinate (DVS) SR
2	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Measured: Baseline and Week 4
Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Measured: Baseline and Week 12
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Measured: Baseline and Week 4
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Measured: Baseline and Week 12
Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.
Measured: Baseline up to Month 12

Secondary outcomes (21)

Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes
A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.
Measured: Baseline and Week 12
Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Measured: Baseline, Week 4 and Week 12
Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Measured: Baseline, Week 4 and Week 12
Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes
Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.
Measured: Week 12
Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12
Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.
Measured: Baseline and Week 12
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.
Measured: Baseline and Month 6
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12
GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.
Measured: Baseline and Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Month 6
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Month 6
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12
PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).
Measured: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Month 6
Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Month 6
Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12
PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008May 2010

First posted23 May 2008 (estimated)
Study startJun 2008
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Vasomotor SymptomsStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 2,186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00683800
Sponsor's protocol ID: 3151A2-3353
Other IDs: B2061011
Status last verified: Jul 2011
First submitted: 21 May 2008
Last updated: 17 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.
PubMed 23266840
Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.
PubMed 23266839
Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.
PubMed 23010882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause
ClinicalTrials.gov ID: NCT00683800
Acronym / sponsor ID: 3151A2-3353
Conditions: Vasomotor Symptoms
Keywords: Menopause, Hot Flush, Hot Flash, Desvenlafaxine succinate Sustained Release
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,186 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 23 May 2008 (estimated)
Results: Posted 17 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: desvenlafaxine succinate (DVS) SRdesvenlafaxine succinate (DVS) SR
2	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Generally healthy, postmenopausal women who seek treatment for hot flushes
Body Mass Index (BMI) less than or equal to 34 kg/m^2

Key exclusion criteria (3 listed)

Hypersensitivity to Venlafaxine
Myocardial infarction an/or unstable angina within 6 months of screening
History of seizure disorder

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
desvenlafaxine succinate (DVS) SRTitration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.	Drug	1
PlaceboTitration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.	Drug	2

Primary outcome

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
Time frame: Baseline and Week 4
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
Time frame: Baseline and Week 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
Time frame: Baseline and Week 4
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
Time frame: Baseline and Week 12
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
Time frame: Baseline up to Month 12
Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.

21 secondary outcomes

Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes
Time frame: Baseline and Week 12
Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
Time frame: Baseline, Week 4 and Week 12
Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
Time frame: Baseline, Week 4 and Week 12
Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes
Time frame: Week 12
Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12
Time frame: Baseline and Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12
Time frame: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6
Time frame: Month 6
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12
Time frame: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12
Time frame: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6
Time frame: Month 6
Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12
Time frame: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12
Time frame: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6
Time frame: Month 6
Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12
Time frame: Month 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12
Time frame: Week 12
Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6
Time frame: Month 6
Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12
Time frame: Month 12

Results and safety

Results posted to the registry on 17 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DVS SR 100 mg	1,101	669
Placebo	1,085	719

Primary outcome: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4

Time frame: Baseline and Week 4. Mean (Standard Error). Unit: Hot Flushes

Measure	DVS SR 100 mg n = 183	Placebo n = 180
Value	-6.52 (0.33)	-3.64 (0.33)

DVS SR 100 mg vs Placebo: Adjusted Mean Difference: -2.89 (95% CI -3.80 to -1.98), p <0.001, ANCOVA

Population analysed: Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.

Primary outcome: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: Hot Flushes

Measure	DVS SR 100 mg n = 184	Placebo n = 181
Value	-7.31 (0.35)	-4.52 (0.35)

DVS SR 100 mg vs Placebo: Adjusted Mean Difference: -2.79 (95% CI -3.77 to -1.82), p <0.001, ANCOVA

Population analysed: MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.

Primary outcome: Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4

Time frame: Baseline and Week 4. Mean (Standard Error). Unit: Units on a Scale

Measure	DVS SR 100 mg n = 183	Placebo n = 180
Value	-0.47 (0.04)	-0.19 (0.04)

DVS SR 100 mg vs Placebo: Adjusted Mean Difference: -0.28 (95% CI -0.40 to -0.16), p <0.001, ANCOVA

Population analysed: MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.

Primary outcome: Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: Units on a Scale

Measure	DVS SR 100 mg n = 184	Placebo n = 181
Value	-0.59 (0.05)	-0.28 (0.05)

DVS SR 100 mg vs Placebo: Adjusted Mean Difference: -0.31 (95% CI -0.44 to -0.18), p <0.001, ANCOVA

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DVS SR 100 mg	43 of 1,066 (4%)	941 of 1,066 (88.3%)	Not reported
Placebo	36 of 1,052 (3.4%)	872 of 1,052 (82.9%)	Not reported

Limitations and caveats (from the sponsor): GCS scales were analyzed only for main study efficacy population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23266840Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.
Derived from this study: PubMed 23266839Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.
Derived from this study: PubMed 23010882Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.
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

121 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing desvenlafaxine succinate (DVS) SR in people with Vasomotor Symptoms, run by Pfizer at 121 sites in 2 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 2 inclusion and 3 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 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 (time frame: Baseline and Week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00683800, which also lists 3 linked publications.

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 17 Aug 2011.