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NCT00853229 · ClinicalTrials.gov registry record · Phase 2

Pregabalin for the Treatment of Vulvodynia

A Phase 2 study, sponsored by The Cleveland Clinic.

Terminated
Registry status
Phase 2
Development phase
16
Enrollment target

NCT00853229: Clinical Trial Phase 2 study, sponsored by The Cleveland Clinic.

NCT00853229 is a Phase 2 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00853229, a Phase 2 study, was terminated before completion, sponsored by The Cleveland Clinic.

TERMINATED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Primary Outcome

The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a ≥50% reduction in pain using this scale. The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the d

Interventions

  • DRUG pregabalin

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2009-02
Est. Completion 2013-04
Phase Phase 2
The Cleveland Clinic

688 total trials

Why NCT00853229 stopped before completion

NCT00853229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which pregabalin is the first listed.

NCT00853229 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00853229 about?

NCT00853229 is a clinical study titled "Pregabalin for the Treatment of Vulvodynia". The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

What is the current status of trial NCT00853229?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-02. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00853229?

The interventions under investigation include: pregabalin (DRUG).

Who is sponsoring clinical trial NCT00853229?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00853229's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00853229, the US trial registry maintained by the National Library of Medicine. NCT00853229 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.