Vasomotor SymptomsPhase 3NCT00401245

The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

A Phase 3 study testing desvenlafaxine succinate sustained release in people with Vasomotor Symptoms, run by Pfizer at 74 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Vasomotor Symptoms
What is being tested?: desvenlafaxine succinate sustained release
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 74 sitesin 3 countries
Study dates: Dec 2006to Jan 2008
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Who cannot join

History of a seizure disorder other than a single childhood febrile seizure.
History or presence of clinically important hepatic or renal disease or other medical disease.
Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.

Trial locations and contacts

74 sites in 3 countries.

Country

City, postcode or hospital

74 sites in 3 countries

United States55 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Albuquerque, New Mexico, 87131
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Bismarck, North Dakota, 58501
Pfizer Investigational Site
Canton, Michigan, 48187
Pfizer Investigational Site
Carrollton, Texas, 75006
Pfizer Investigational Site
Champaign, Illinois, 61820
Pfizer Investigational Site
Chapel Hill, North Carolina, 27514
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Crystal River, Florida, 34429
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Encinitas, California, 92024
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fargo, North Dakota, 58104
Pfizer Investigational Site
Foothill Ranch, California, 92610
Pfizer Investigational Site
Gainesville, Florida, 32606
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Hurst, Texas, 76054
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Lebanon, New Hampshire, 03755
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Longmont, Colorado, 80501
Pfizer Investigational Site
Louisville, Kentucky, 40291
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Midland, Texas, 79705
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Omaha, Nebraska, 68131-2197
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tucson, Arizona, 85710
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Watertown, South Dakota, 57201
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103-4005
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Ypsilanti, Michigan, 48197

Other trials in United States

Canada18 sites

Pfizer Investigational Site
Calgary, Alberta, T2N 4L7
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
Montreal, Quebec, H2X 1N8
Pfizer Investigational Site
Newmarket, Ontario, L3Y 5G8
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Québec, Quebec, G1V 4X7
Pfizer Investigational Site
Saint Romuald, Quebec, G6W 5M6
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Shawinigan, Quebec, G9N 2H6
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 4J6
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2
Pfizer Investigational Site
Surrey, British Columbia, V4A 2H9
Pfizer Investigational Site
Toronto, Ontario, M4S 1Y2
Pfizer Investigational Site
Toronto, Ontario, M5C 1R6
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M3
Pfizer Investigational Site
Winnipeg, Manitoba, R3T 2E8

Other trials in Canada

Location not given1 site

Pfizer Investigational Site

About this study

Official title: The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Conditions: Vasomotor Symptoms
Being tested: desvenlafaxine succinate sustained release, Placebo

What participants receive

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

desvenlafaxine succinate sustained releaseDrug
Titration 100 mg
desvenlafaxine succinate sustained releaseDrug
Titration 50 mg
desvenlafaxine succinate sustained releaseDrug
Titration 25 mg, 50mg
desvenlafaxine succinate sustained releaseDrug
Titration 25 mg
PlaceboDrug
Tapering placebo
desvenlafaxine succinate sustained releaseDrug
Tapering 50 mg, placebo
desvenlafaxine succinate sustained releaseDrug
Tapering 50 mg, 25 mg
desvenlafaxine succinate sustained releaseDrug
Tapering 50 mg QOD

Study groups in NCT00401245
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
B	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
C	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
D	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
E	Active comparator	Not described Receives: Drug: Placebo
F	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
G	Active comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release
H	Placebo comparator	Not described Receives: Drug: desvenlafaxine succinate sustained release

What is being measured

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

Number of Participants With Nausea During the First 2 Weeks of Treatment
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Measured: Baseline up to Week 2
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Measured: Week 17
DESS Total Score at End of Second Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Measured: Week 18
DESS Total Score at 1 Week After the End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Measured: Week 19

Secondary outcomes (9)

Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Measured: Baseline up to Week 2
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Measured: Baseline up to Week 2
Number of Participants With Each DESS at the End of First Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Measured: Week 17
Number of Participants With Each DESS at the End of Second Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Measured: Week 18
Number of Participants With Each DESS One Week After End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Measured: Week 19
Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Measured: Week 1 and Week 2
Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Measured: Week 19
Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).
Measured: Week 16
Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.
Measured: Baseline, Week 4, Week 8, Week 12 and Week 16

Timeline

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

Dec 2006Jan 2008

First posted20 Nov 2006 (estimated)
Study startDec 2006
Primary completionJan 2008
Study completionJan 2008

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.
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: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401245
Sponsor's protocol ID: 3151A2-405
Status last verified: Oct 2011
First submitted: 17 Nov 2006
Last updated: 26 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
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RecruitingPhase 3
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All Vasomotor Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study
ClinicalTrials.gov ID: NCT00401245
Acronym / sponsor ID: 3151A2-405
Conditions: Vasomotor Symptoms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 20 Nov 2006 (estimated)
Results: Posted 12 Oct 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: 8

Arm	Type	Receives
A	Active comparator	Drug: desvenlafaxine succinate sustained release
B	Active comparator	Drug: desvenlafaxine succinate sustained release
C	Active comparator	Drug: desvenlafaxine succinate sustained release
D	Active comparator	Drug: desvenlafaxine succinate sustained release
E	Active comparator	Drug: Placebo
F	Active comparator	Drug: desvenlafaxine succinate sustained release
G	Active comparator	Drug: desvenlafaxine succinate sustained release
H	Placebo comparator	Drug: desvenlafaxine succinate sustained release

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Key exclusion criteria (3 listed)

History of a seizure disorder other than a single childhood febrile seizure.
History or presence of clinically important hepatic or renal disease or other medical disease.
Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.

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 sustained releaseTitration 100 mg	Drug	A
desvenlafaxine succinate sustained releaseTitration 50 mg	Drug	B
desvenlafaxine succinate sustained releaseTitration 25 mg, 50mg	Drug	C
desvenlafaxine succinate sustained releaseTitration 25 mg	Drug	D
PlaceboTapering placebo	Drug	E
desvenlafaxine succinate sustained releaseTapering 50 mg, placebo	Drug	F
desvenlafaxine succinate sustained releaseTapering 50 mg, 25 mg	Drug	G
desvenlafaxine succinate sustained releaseTapering 50 mg QOD	Drug	H

Primary outcome

Number of Participants With Nausea During the First 2 Weeks of Treatment
Time frame: Baseline up to Week 2
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
Time frame: Week 17
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS Total Score at End of Second Week of Tapering
Time frame: Week 18
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS Total Score at 1 Week After the End of Tapering
Time frame: Week 19
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.

9 secondary outcomes

Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Time frame: Baseline up to Week 2
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Time frame: Baseline up to Week 2
Number of Participants With Each DESS at the End of First Week of Tapering
Time frame: Week 17
Number of Participants With Each DESS at the End of Second Week of Tapering
Time frame: Week 18
Number of Participants With Each DESS One Week After End of Tapering
Time frame: Week 19
Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Time frame: Week 1 and Week 2
Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Time frame: Week 19
Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
Time frame: Week 16
Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
Time frame: Baseline, Week 4, Week 8, Week 12 and Week 16

Results and safety

Results posted to the registry on 12 Oct 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 25 mg, Then 100 mg	126	122
DVS 25/50 mg, Then 100 mg	121	118
DVS 50 mg, Then 100 mg	124	118
DVS 100 mg, Then 100 mg	122	107
DVS 50 mg QOD	0	0
DVS 50/25 mg	0	0
DVS 50 mg/Placebo	0	0
Placebo	0	0

Primary outcome: Number of Participants With Nausea During the First 2 Weeks of Treatment

Time frame: Baseline up to Week 2. Number. Unit: Participants

Measure	DVS 25 mg, Then 100 mg n = 126	DVS 25/50 mg, Then 100 mg n = 121	DVS 50 mg, Then 100 mg n = 124	DVS 100 mg, Then 100 mg n = 122
Value	24	31	28	43

DVS 25 mg, Then 100 mg vs DVS 25/50 mg, Then 100 mg vs DVS 50 mg, Then 100 mg vs DVS 100 mg, Then 100 mg: p = 0.024, Chi-squared

Population analysed: The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.

Primary outcome: Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering

Time frame: Week 17. Mean (Standard Deviation). Unit: Units on a scale

Measure	DVS 50 mg QOD n = 100	DVS 50/25 mg n = 86	DVS 50 mg/Placebo n = 83	Placebo n = 98
Value	2.26 (3.46)	2.28 (3.59)	1.84 (3.36)	7.07 (7.13)

DVS 50 mg QOD vs Placebo: p < 0.001, ANOVA
DVS 50/25 mg vs Placebo: p <0.001, ANOVA
DVS 50 mg/Placebo vs Placebo: p <0.001, ANOVA

Population analysed: The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.

Primary outcome: DESS Total Score at End of Second Week of Tapering

Time frame: Week 18. Mean (Standard Deviation). Unit: Units on a scale

Measure	DVS 50 mg QOD n = 89	DVS 50/25 mg n = 87	DVS 50 mg/Placebo n = 79	Placebo n = 91
Value	1.19 (1.96)	2.44 (5.53)	4.46 (6.44)	2.44 (4.96)

DVS 50 mg QOD vs Placebo: p = 0.092, ANOVA
DVS 50/25 mg vs Placebo: p = 0.997, ANOVA
DVS 50 mg/Placebo vs Placebo: p = 0.009, ANOVA

Population analysed: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.

Primary outcome: DESS Total Score at 1 Week After the End of Tapering

Time frame: Week 19. Mean (Standard Deviation). Unit: Units on a scale

Measure	DVS 50 mg QOD n = 59	DVS 50/25 mg n = 57	DVS 50 mg/Placebo n = 47	Placebo n = 59
Value	3.22 (4.82)	4.11 (5.77)	1.70 (3.16)	1.78 (3.20)

DVS 50 mg QOD vs Placebo: p = 0.078, ANOVA
DVS 50/25 mg vs Placebo: p = 0.005, ANOVA
DVS 50 mg/Placebo vs Placebo: p = 0.929, ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DVS 25 mg (Titration Phase)	0 of 126 (0%)	50 of 126 (39.7%)	Not reported
DVS 25/50 mg (Titration Phase)	0 of 121 (0%)	55 of 121 (45.5%)	Not reported
DVS 50 mg (Titration Phase)	0 of 124 (0%)	57 of 124 (46%)	Not reported
DVS 100 mg (Titration Phase)	0 of 122 (0%)	73 of 122 (59.8%)	Not reported
DVS 100 mg (OL Phase)	3 of 461 (0.7%)	340 of 461 (73.8%)	Not reported
DVS 50 mg QOD (Tapering Phase)	0 of 101 (0%)	74 of 101 (73.3%)	Not reported
DVS 50/25 mg (Tapering Phase)	0 of 94 (0%)	64 of 94 (68.1%)	Not reported
DVS 50 mg/Placebo (Tapering Phase)	0 of 87 (0%)	67 of 87 (77%)	Not reported
Placebo (Tapering Phase)	1 of 102 (1%)	79 of 102 (77.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Vasomotor Symptoms

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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

74 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing desvenlafaxine succinate sustained release in people with Vasomotor Symptoms, run by Pfizer at 74 sites in 3 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 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 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 12 Oct 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?

Number of Participants With Nausea During the First 2 Weeks of Treatment (time frame: Baseline up to Week 2). The study lists 4 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 NCT00401245.

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 26 Oct 2011.