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A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response
NCT01301001 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01301001
The ClinicalTrials.gov registry entry for NCT01301001 describes a study currently listed as completed. It is categorized as NA, 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 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 58 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 Vulvodynia appearing as the primary indexed condition, and to 2 interventions — of which Placebo oral capsule 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: NCT01301001 reports 3 study locations spanning 3 distinct geographic areas — top geographies include New Jersey, New York, Tennessee. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01301001?
The interventions under investigation include: Placebo oral capsule (DRUG), Gabapentin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01301001?
This trial is sponsored by University of Tennessee, which has 58 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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