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NCT01301001 · ClinicalTrials.gov registry record · NA

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

A NA study of Vulvodynia, sponsored by University of Tennessee.

Completed
Registry status
NA
Development phase
230
Enrollment target
3
Study locations

NCT01301001 is a NA study of Vulvodynia that has completed, run by University of Tennessee. The registered enrollment target is 230 participants, above the 112-participant average among 9 other Vulvodynia trials with a reported enrollment target (105% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT01301001, a NA study of Vulvodynia, has completed, sponsored by University of Tennessee.

COMPLETED
Registry status
NA
Development phase
230 participants
Enrollment target
3
Study locations

Study Summary

The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.

Conditions Studied

Vulvodynia

Interventions

  • DRUG Placebo oral capsule
  • DRUG Gabapentin

Study Locations (3)

New Jersey

  • Rutgers - Robert Wood Johnson Medical School - New Brunswick

New York

  • University of Rochester School of Medicine and Dentistry - Rochester

Tennessee

  • Clinical Research Center - Memphis

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2012-08
Est. Completion 2016-01
Phase NA

Sponsor

University of Tennessee

96 total trials

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What the Registry Record Tells You About NCT01301001

The ClinicalTrials.gov registry entry for NCT01301001 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 112-participant average among 9 other Vulvodynia trials with a reported enrollment target (105% higher). The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vulvodynia appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT01301001 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New Jersey, New York, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01301001 about?

NCT01301001 is a clinical study titled "A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response". The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform ...

What is the current status of trial NCT01301001?

This trial is currently completed. It is a NA study. The enrollment target is 230 participants. The study started on 2012-08. Estimated completion is 2016-01.

What conditions does trial NCT01301001 study?

This clinical trial studies the following conditions: Vulvodynia.

What interventions are being tested in trial NCT01301001?

The interventions under investigation include: Placebo oral capsule (DRUG), Gabapentin (DRUG).

Who is sponsoring clinical trial NCT01301001?

This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01301001 being conducted?

This trial has 3 study locations across New Jersey, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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