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NCT00401245 · ClinicalTrials.gov registry record · Phase 3
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT00401245 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 500 participants.
The verdict
NCT00401245, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG desvenlafaxine succinate sustained release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401245
The ClinicalTrials.gov registry entry for NCT00401245 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00401245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00401245 about?
NCT00401245 is a clinical study titled "The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms". 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 d...
What is the current status of trial NCT00401245?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2006-12. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00401245?
The interventions under investigation include: Placebo (DRUG), desvenlafaxine succinate sustained release (DRUG).
Who is sponsoring clinical trial NCT00401245?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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