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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: Completed NA study of Vulvodynia, sponsored by University of Tennessee.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT01301001 record still lists
NCT01301001 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 112-participant average among 9 other Vulvodynia trials with a reported enrollment target (105% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Vulvodynia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01301001's enrollment target sits among peer trials
230 2nd of 9 the highest of 9 other Vulvodynia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vulvodynia 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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