Trial · NCT03844412

Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

NCT03844412, Phase 2, Completed, Duke University; results first posted 2026-03-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments. Trials, record NCT03844412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03844412

On this page

Trial

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

Title: Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
NCT number: NCT03844412
Status: Completed
Phases: Phase 2
Enrollment: 209 participants, actual
Lead sponsor: Duke University
Conditions: Vestibulodynia, Temporomandibular Disorder, Fibromyalgia Syndrome, Irritable Bowel Syndrome, Migraines, Tension Headache, Endometriosis, Interstitial Cystitis, Back Pain, Chronic Fatigue Syndrome
Interventions: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, Placebo cream, Placebo pill
First posted: 2019-02-18
Last updated: 2026-03-19
Results first posted: 2026-03-19

Source ClinicalTrials.gov

Registered outcomes24

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

List	Outcome	Time frame	Description
Primary	Pain Score During the Tampon Test	Baseline, 16 weeks	The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain.
Primary	Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)	Baseline, 16 weeks	The SF-MPQ consists of 15 descriptors which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The total score ranges from 0 to 45, where a higher score indicates greater pain. A negative change score indicates a decrease in pain over time.
Primary	Self-reported Physical Health Via SF-12 Health Survey (SF12v2)	Prior to randomization	The SF-12 physical health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Primary	Self-reported Mental Health Via SF-12 Health Survey (SF12v2)	Prior to randomization	The SF-12 mental health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Primary	Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline, 16 weeks	The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. The PROMIS Sexual Function and Satisfaction (SexFS) measures produce a T-score that summarizes a person's sexual health. The T-score is a standardized score that ranges from 0 to 100, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate greater satisfaction.
Secondary	Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)	Baseline, 8 weeks, and 16 weeks	Vaginal Vestibule PPIs will be determined using a cotton swab applied to externally-accessed sites (at 10, 6, and 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10, where 0 = no pain and 10 = the worst pain possible. Reported as a composite mean score.
Secondary	Change in Levator Muscle Complex Pressure Pain Threshold (PPT)	Baseline, 16 weeks	Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the left puborectalis levator muscles site (7 o'clock) just lateral to the perineum. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.
Secondary	Change in Pain Level as Measured by Remote Bodily PPTs	Baseline, 8 weeks, and 16 weeks	Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. PPT scores are rated on a scale of 0-10, where 0 meaning no pain and 10 meaning the worst pain possible. Reported as a composite mean score.
Secondary	Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)	Baseline, 8 weeks, and 16 weeks	Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from "never" (0) to "more than once a week" (4). The total score ranges from 0 to 216, where greater scores indicate greater frequency of symptoms.
Secondary	Change in Sleep as Measured by the Sleep Scale	Baseline, 8 weeks, 16 weeks, and 24 weeks	The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain Score During the Tampon Test	Baseline, 16 weeks	Participants with data at both time points are included.	score on a scale	MEAN
PRIMARY	Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)	Baseline, 16 weeks	Participants with data collected at both timepoints.	score on a scale	MEAN
PRIMARY	Self-reported Physical Health Via SF-12 Health Survey (SF12v2)	Prior to randomization	Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype.	score on a scale	MEAN
PRIMARY	Self-reported Mental Health Via SF-12 Health Survey (SF12v2)	Prior to randomization	Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype.	score on a scale	MEAN
PRIMARY	Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline, 16 weeks	Participants with data collected at each timepoint.	score on a scale	MEAN
SECONDARY	Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)	Baseline, 8 weeks, and 16 weeks	Participants with data collected at both timepoints for each comparison.	score on a scale	MEAN
SECONDARY	Change in Levator Muscle Complex Pressure Pain Threshold (PPT)	Baseline, 16 weeks	Participants with data collected at both timepoints.	kPa	MEAN
SECONDARY	Change in Pain Level as Measured by Remote Bodily PPTs	Baseline, 8 weeks, and 16 weeks	Participants with data collected at both timepoints for each comparison.	score on a scale	MEAN
SECONDARY	Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)	Baseline, 8 weeks, and 16 weeks	Participants with data collected at each timepoint.	score on a scale	MEAN
SECONDARY	Change in Sleep as Measured by the Sleep Scale	Baseline, 8 weeks, 16 weeks, and 24 weeks	Study team believed data was being collected, but sleep scale was inadvertently not included in the REDCap survey follow-ups.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group707

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

Outcome	Group	Category	Value	Spread	Units
Pain Score During the Tampon Test	Combined Peripheral and Central Treatments	Baseline	4.37	Standard Error 0.30	score on a scale
Pain Score During the Tampon Test	Peripheral Treatment	Baseline	3.75	Standard Error 0.29	score on a scale
Pain Score During the Tampon Test	Central Treatment	Baseline	4.04	Standard Error 0.36	score on a scale
Pain Score During the Tampon Test	Placebo	Baseline	4.36	Standard Error 0.25	score on a scale
Pain Score During the Tampon Test	Combined Peripheral and Central Treatments	16 weeks	3.02	Standard Error 0.33	score on a scale
Pain Score During the Tampon Test	Peripheral Treatment	16 weeks	2.66	Standard Error 0.36	score on a scale
Pain Score During the Tampon Test	Central Treatment	16 weeks	3.22	Standard Error 0.41	score on a scale
Pain Score During the Tampon Test	Placebo	16 weeks	3.64	Standard Error 0.39	score on a scale
Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)	Combined Peripheral and Central Treatments		-5.17	Standard Error 1.05	score on a scale
Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)	Peripheral Treatment		-5.08	Standard Error 0.97	score on a scale

1 to 10 of 707Source ClinicalTrials.gov

See all 707 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Combined Peripheral and Central Treatments	52
Overall Study	STARTED	Peripheral Treatment	52
Overall Study	STARTED	Central Treatment	52
Overall Study	STARTED	Placebo	53
Overall Study	COMPLETED	Combined Peripheral and Central Treatments	40
Overall Study	COMPLETED	Peripheral Treatment	34
Overall Study	COMPLETED	Central Treatment	47
Overall Study	COMPLETED	Placebo	45
Overall Study	NOT COMPLETED	Combined Peripheral and Central Treatments	12
Overall Study	NOT COMPLETED	Peripheral Treatment	18

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events160

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
other	Swelling	General disorders	Combined Peripheral and Central Treatments	0	52
other	Swelling	General disorders	Peripheral Treatment	0	52
other	Swelling	General disorders	Central Treatment	0	52
other	Swelling	General disorders	Placebo	0	53
other	Burning	General disorders	Combined Peripheral and Central Treatments	1	52
other	Burning	General disorders	Peripheral Treatment	2	52
other	Burning	General disorders	Central Treatment	0	52
other	Burning	General disorders	Placebo	3	53
other	Blistering	General disorders	Combined Peripheral and Central Treatments	0	52
other	Blistering	General disorders	Peripheral Treatment	0	52

1 to 10 of 160Source ClinicalTrials.gov

See all 160 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combined Peripheral and Central Treatments	0	52
Total, all-cause mortality	Peripheral Treatment	0	52
Total, all-cause mortality	Central Treatment	0	52
Total, all-cause mortality	Placebo	0	53
Total, other adverse events	Combined Peripheral and Central Treatments	32	52
Total, other adverse events	Peripheral Treatment	19	52
Total, other adverse events	Central Treatment	33	52
Total, other adverse events	Placebo	27	53
Total, serious adverse events	Combined Peripheral and Central Treatments	1	52
Total, serious adverse events	Peripheral Treatment	0	52

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36269028	DERIVED	PubMed
42857927	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD096331	Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)	NACKLEY, ANDREA G	DUKE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2018 to 2024

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT03844412

GET https://conductscience.org/api/trials/v1/NCT03844412/registered?page=2

API reference For AI assistants