CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 209 enrolled
Drug / intervention
5% lidocaine/5 mg/ml 0.02% estradiol compound cream +3 moredrug
Likely dose
5% lidocaine/5 mg/ml 0.02% estradiol compound creamfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03844412
NCT03844412Phase 2Completed
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Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

Duke University·interventional·Posted Feb 18, 2019·Updated Mar 19, 2026

In Brief

A Phase 2 clinical trial evaluating 5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, and 2 other interventions for Vestibulodynia and 9 related conditions. Completed, enrolled 209 participants across 2 sites.

Detailed Summary

Vestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United States. Here, the investigators plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes. Positive findings from this study will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and their clinicians to make more informed decisions about pain management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVestibulodynia, Temporomandibular Disorder, Fibromyalgia Syndrome, Irritable Bowel Syndrome, Migraines, Tension Headache, Endometriosis, Interstitial Cystitis, Back Pain, Chronic Fatigue Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 18, 2019
Enrollment StartNov 4, 2019
Primary CompletionMar 13, 2024
Study CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.4 years ago

Interventions

5% lidocaine/5 mg/ml 0.02% estradiol compound creamdrug

Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4).

Nortriptylinedrug

Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline.

Placebo creamdrug

The comparison treatment will be an identical-appearing placebo Moisturel™ cream

Placebo pilldrug

The comparison treatment will be an identical-appearing placebo pill