Trial · NCT01301001

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

NCT01301001, Not applicable, Completed, University of Tennessee; results first posted 2017-11-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response. Trials, record NCT01301001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01301001

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response
NCT number: NCT01301001
Status: Completed
Phases: Not applicable
Enrollment: 230 participants, actual
Lead sponsor: University of Tennessee
Conditions: Vulvodynia
Interventions: Placebo oral capsule, Gabapentin
First posted: 2011-02-23
Last updated: 2017-11-08
Results first posted: 2017-11-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Tampon Test Pain Intensity	Week 6 for each treatment arm	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).
Secondary	Coital Pain	Week 6 of each treatment arm	Coital pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever), assessed after each sexual intercourse event. The number of sexual intercourse events was averaged during final week of each treatment arm.
Secondary	Vulvodynia Pain	Week 6 for each treatment arm	Overall vulvodynia pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). Pain was assessed daily during the last week of treatment. Daily scores were averaged.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Tampon Test Pain Intensity	Week 6 for each treatment arm	Intention to Treat	units on a scale	MEAN
SECONDARY	Coital Pain	Week 6 of each treatment arm	Intent to treat	units on a scale	MEAN
SECONDARY	Vulvodynia Pain	Week 6 for each treatment arm		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Tampon Test Pain Intensity	Placebo	4.29	95% Confidence Interval 3.37 to 5.22	units on a scale
Tampon Test Pain Intensity	Gabapentin	3.96	95% Confidence Interval 3.03 to 4.89	units on a scale
Coital Pain	Placebo	3.97	95% Confidence Interval 2.50 to 5.44	units on a scale
Coital Pain	Gabapentin	3.85	95% Confidence Interval 2.36 to 5.34	units on a scale
Vulvodynia Pain	Placebo	2.88	95% Confidence Interval 1.99 to 3.76	units on a scale
Vulvodynia Pain	Gabapentin	2.71	95% Confidence Interval 1.82 to 3.59	units on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	Placebo First, Then Gabepentin	44
First Intervention	STARTED	Gabapentin First, Then Placebo	45
First Intervention	COMPLETED	Placebo First, Then Gabepentin	34
First Intervention	COMPLETED	Gabapentin First, Then Placebo	36
First Intervention	NOT COMPLETED	Placebo First, Then Gabepentin	10
First Intervention	NOT COMPLETED	Gabapentin First, Then Placebo	9
Washout (2 Weeks)	STARTED	Placebo First, Then Gabepentin	34
Washout (2 Weeks)	STARTED	Gabapentin First, Then Placebo	36
Washout (2 Weeks)	COMPLETED	Placebo First, Then Gabepentin	34
Washout (2 Weeks)	COMPLETED	Gabapentin First, Then Placebo	36

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Placebo	3	89	3
other	Dizziness	Nervous system disorders	Gabapentin	9	89	17
other	Fatigue	Nervous system disorders	Placebo	1	89	1
other	Fatigue	Nervous system disorders	Gabapentin	5	89	7
other	Headache	Nervous system disorders	Placebo	5	89	7
other	Headache	Nervous system disorders	Gabapentin	7	89	15
other	Somnolence	Nervous system disorders	Placebo	4	89	4
other	Somnolence	Nervous system disorders	Gabapentin	7	89	7
other	Rhinitis	Infections and infestations	Placebo	4	89	4
other	Rhinitis	Infections and infestations	Gabapentin	10	89	14

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	89
Total, all-cause mortality	Gabapentin	0	89
Total, other adverse events	Placebo	20	89
Total, other adverse events	Gabapentin	31	89
Total, serious adverse events	Placebo	1	89
Total, serious adverse events	Gabapentin	0	89

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29742655	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gabapentin vs Placebo: deaths from any cause	Trial comparisons
Gabapentin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01301001

GET https://conductscience.org/api/trials/v1/NCT01301001/registered

API reference For AI assistants