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COMPLETED Phase 3

Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

NCT00421031 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.

Conditions Studied

Interventions

  • DRUG DVS-233 SR

Study Locations (20)

Florida

  • — Aventura
  • — Fort Myers
  • — Inverness
  • — Miami
  • — New Port Richey
  • — Ocala
  • — Orange City
  • — Pinellas Park
  • — Tampa
  • — West Palm Beach
  • — West Venice

California

  • — San Diego
  • — Stanford

Georgia

  • — Atlanta
  • — Savannah

Alabama

  • — Montgomery

Arizona

  • — Peoria

Colorado

  • — Colorado Springs

Delaware

  • — Newark

Indiana

  • — Newburgh

Trial Details

FieldValue
Enrollment Target 540 participants
Start Date 2003-12
Est. Completion 2004-04
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00421031

The ClinicalTrials.gov registry entry for NCT00421031 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Vasomotor Symptoms appearing as the primary indexed condition, and to 1 intervention — of which DVS-233 SR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00421031 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00421031 about?

NCT00421031 is a clinical study titled "Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause". The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health ou...

What is the current status of trial NCT00421031?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2003-12. Estimated completion is 2004-04.

What conditions does trial NCT00421031 study?

This clinical trial studies the following conditions: Vasomotor Symptoms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00421031?

The interventions under investigation include: DVS-233 SR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00421031?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00421031 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial