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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.

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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

FieldValue
Enrollment Target 500 participants
Start Date 2006-12
Est. Completion 2008-01
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.