Vasomotor SymptomsPhase 1NCT00397176
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
A Phase 1 study testing desvenlafaxine succinate sustained release (DVS SR) in people with Vasomotor Symptoms, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- desvenlafaxine succinate sustained release (DVS SR)
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Feb 2007
- Phase
- Phase 1
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, first-generation (born in Japan, living in the US for less than 5 years)
- Japanese female subjects
Who cannot join
None listed.
About this study
Official title: Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.
- Conditions
- Vasomotor Symptoms
- 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.
Safety, Tolerability, PK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startNov 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 Vasomotor SymptomsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 32 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
- NCT00397176
- Sponsor's protocol ID
- 3151A2-1200
- Status last verified
- Dec 2007
- First submitted
- 7 Nov 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects
- ClinicalTrials.gov ID
- NCT00397176
- Acronym / sponsor ID
- 3151A2-1200
- Conditions
- Vasomotor Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 8 Nov 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.
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, first-generation (born in Japan, living in the US for less than 5 years)
- Japanese female subjects
Key exclusion criteria (0 listed)
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
Safety, Tolerability, PK
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 28 Dec 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing desvenlafaxine succinate sustained release (DVS SR) in people with Vasomotor Symptoms, 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 2 inclusion and 0 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 28 Dec 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety, Tolerability, PK. 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 28 Dec 2007.