MenopausePhase 3NCT00256685
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
A Phase 3 study testing DVS-233 SR in people with Menopause and Hot Flashes, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Menopause, Hot Flashes, Sleep Disorders
- What is being tested?
- DVS-233 SR
- How many people
- 568 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jul 2005
- Phase
- Phase 3
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Generally healthy, postmenopausal women who seek treatment for hot flushes
- Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- Other inclusions apply.
Who cannot join
- Hypersensitivity to Venlafaxine
- History of seizure disorder
- History of myocardial infarction or unstable angina within 6 months
- Other exclusions apply.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.
- Conditions
- Menopause, Hot Flashes, Sleep Disorders
- Being tested
- DVS-233 SR
- Keywords
- Menopause
- Medical subject headings
- Hot Flashes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVS-233 SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Secondary outcomes (1)
Sleep, mood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 568 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256685
- Sponsor's protocol ID
- 3151A2-319
- Status last verified
- May 2006
- First submitted
- 17 Nov 2005
- Last updated
- 19 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
- ClinicalTrials.gov ID
- NCT00256685
- Acronym / sponsor ID
- 3151A2-319
- Conditions
- Menopause, Hot Flashes, Sleep Disorders
- Keywords
- Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jul 2005
- First posted
- 21 Nov 2005 (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 purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Generally healthy, postmenopausal women who seek treatment for hot flushes
- Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- Other inclusions apply.
Key exclusion criteria (4 listed)
- Hypersensitivity to Venlafaxine
- History of seizure disorder
- History of myocardial infarction or unstable angina within 6 months
- Other exclusions apply.
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 |
|---|---|---|
| DVS-233 SR | Drug | – |
Primary outcome
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
1 secondary outcome
Sleep, mood
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 19 May 2006.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DVS-233 SR in people with Menopause and Hot Flashes, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 4 inclusion and 4 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 19 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 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 19 May 2006.