MenopausePhase 3NCT00369434
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
A Phase 3 study testing Desvenlafaxine succinate sustained-release (DVS SR) in people with Menopause and Vasomotor System, run by Wyeth is now a wholly owned subsidiary of Pfizer at 34 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Vasomotor System
- What is being tested?
- Desvenlafaxine succinate sustained-release (DVS SR)
- How many people
- 450 participants
- Where
- 34 sitesUnited States
- Study dates
- Jun 2006to Feb 2007
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, 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 40 kg/m2
- Other inclusions apply.
Who cannot join
- Hypersensitivity to Venlafaxine
- Myocardial infarction and/or unstable angina within 6 months of screening
- History of seizure disorder
- Other exclusions apply.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Billings, Montana, 59102
Study site
Bismarck, North Dakota, 58501
Study site
Boise, Idaho, 83702
Study site
Brooksville, Florida, 34613
Study site
Cincinnati, Ohio, 45267-0457
Study site
Colorado Springs, Colorado, 80910
Study site
Decatur, Georgia, 30033
Study site
Erie, Pennsylvania, 16502
Study site
Eugene, Oregon, 97401
Study site
Fargo, North Dakota, 58104
Study site
Hilton Head Island, South Carolina, 29926
Study site
Idaho Falls, Idaho, 83404
Study site
Inverness, Florida, 34452
Study site
Las Vegas, Nevada, 89146
Study site
Louisville, Kentucky, 40291
Study site
Miami, Florida, 33143
Study site
Midvale, Utah, 84047
Study site
Montgomery, Alabama, 36106
Study site
New Port Richey, Florida, 34652
Study site
Norfolk, Virginia, 23507
Study site
Ocala, Florida, 34471
Study site
Overland Park, Kansas, 66210
Study site
Peoria, Arizona, 85381
Study site
Philadelphia, Pennsylvania, 19114
Study site
Portland, Maine, 04102
Study site
Richmond, Virginia, 23294
Study site
Rockville, Maryland, 20852
Study site
Savannah, Georgia, 31406
Study site
St. Petersburg, Florida, 33709
Study site
Tampa, Florida, 33606
Study site
Upland, California, 91786
Study site
Wexford, Pennsylvania, 15090
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
Read the detailed description
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.
- Conditions
- Menopause, Vasomotor System
- Being tested
- Desvenlafaxine succinate sustained-release (DVS SR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine succinate sustained-release (DVS SR)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
Secondary outcomes (2)
The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startJun 2006
- Study completionFeb 2007
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
- 450 participants (estimated)
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
- NCT00369434
- Sponsor's protocol ID
- 3151A2-337
- Status last verified
- May 2007
- First submitted
- 25 Aug 2006
- Last updated
- 1 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. 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 SR for Treatment of Vasomotor Symptoms Associated With Menopause
- ClinicalTrials.gov ID
- NCT00369434
- Acronym / sponsor ID
- 3151A2-337
- Conditions
- Menopause, Vasomotor System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 29 Aug 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 purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
Detailed description
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Generally healthy, postmenopausal women who seek treatment for hot flushes
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- Other inclusions apply.
Key exclusion criteria (4 listed)
- Hypersensitivity to Venlafaxine
- Myocardial infarction and/or unstable angina within 6 months of screening
- History of seizure disorder
- 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 |
|---|---|---|
| Desvenlafaxine succinate sustained-release (DVS SR) | Drug | – |
Primary outcome
The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
2 secondary outcomes
The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).
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 1 Jun 2007.
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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
34 sites in 1 country: 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 (DVS SR) in people with Menopause and Vasomotor System, run by Wyeth is now a wholly owned subsidiary of Pfizer at 34 sites in United States.
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 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 1 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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 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?
The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.. 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 1 Jun 2007.