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Local Anesthetic and Estrogen

Nortriptyline + Lidocaine/Estradiol Cream for Vulvar Vestibulitis

Phase 2
Recruiting
Led By Andrea Nackley, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 16 weeks, and 24 weeks
Awards & highlights

Study Summary

This trial will compare different treatments for vestibulodynia, a complex chronic vulvar pain condition, to determine which is most effective in alleviating pain and improving patient-reported outcomes.

Eligible Conditions
  • Vulvodynia
  • Irritable Bowel Syndrome
  • Back Pain
  • Chronic Fatigue Syndrome
  • Temporomandibular Joint Disorder
  • Tension Headache
  • Interstitial Cystitis
  • Migraine
  • Fibromyalgia
  • Endometriosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 16 weeks, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 16 weeks, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in inflammation as measured by cytokine expression levels
Change in pain score during the tampon test
Gene therapy
+3 more
Secondary outcome measures
Change in cytokine biomarkers at other time points
Change in degree of overlapping pain, as measured by COPC follow-up survey
Change in in pain score during the tampon test at other time points
+11 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: central treatmentActive Control2 Interventions
tricyclic antidepressant nortriptyline pill
Group II: combined peripheral and central treatmentsActive Control2 Interventions
5% lidocaine/5 mg/ml 0.02% estradiol compound cream and tricyclic antidepressant nortriptyline pill
Group III: peripheral treatmentActive Control2 Interventions
5% lidocaine/5 mg/ml 0.02% estradiol compound cream
Group IV: placeboPlacebo Group2 Interventions
placebo cream and placebo pill

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,330 Total Patients Enrolled
2 Trials studying Vulvodynia
30,725 Patients Enrolled for Vulvodynia
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,106 Total Patients Enrolled
Andrea Nackley, PhDPrincipal InvestigatorDuke University

Media Library

5% lidocaine/5 mg/ml 0.02% estradiol compound cream (Local Anesthetic and Estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03844412 — Phase 2
Vulvodynia Research Study Groups: central treatment, combined peripheral and central treatments, placebo, peripheral treatment
Vulvodynia Clinical Trial 2023: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream Highlights & Side Effects. Trial Name: NCT03844412 — Phase 2
5% lidocaine/5 mg/ml 0.02% estradiol compound cream (Local Anesthetic and Estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03844412 — Phase 2
Vulvodynia Patient Testimony for trial: Trial Name: NCT03844412 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the past investigations into central treatment?

"Central treatment was first explored in the NIH Clinical Center back in 1996, and since then 1058 trials have been concluded. At present there are 177 studies actively recruiting participants, with many of these occurring at sites around Los Angeles."

Answered by AI

What are the desired outcomes of this medical experiment?

"The primary outcome of this clinical trial, assessed over a 16-week interval from Baseline, is the Alteration in pro-pain and pro-inflammatory gene regulators as determined by microRNA expression levels. Secondary outcomes include Variance in SF-MPQ pain score at other time points; Modification in vaginal vestibule pressure pain intensities (PPI) measured with a cotton swab on 6 externally accessible sites; Levator muscle complex pressure pain thresholds (PPTs) appraised through digital vestibular algometer internally applied to right midline and left puborectalis levator muscles."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to central treatment?

"As this is a Phase 2 medical trial, with some data suggesting safety but none supporting effectiveness (efficacy), our team at Power assigned central treatment a score of two."

Answered by AI

Who is qualified to be an enrollee in this research trial?

"This clinical trial seeks 400 female participants aged 18-50 who suffer from endometrioma and a pain score of 3 or higher on the tampon insertion test."

Answered by AI

Are any additional participants being sought for this research endeavor?

"Yes, the clinical trial hosted on clinicaltrials.gov is open for recruitment and has been updated as recently as December 1st 2022. This study was initially posted to the website on November 4th 2019."

Answered by AI

Are enrollees in this trial limited to adults under the age of 40?

"This study is admitting participants aged 18-50 who meet the criteria."

Answered by AI

What afflictions can be remedied by central treatment?

"Central treatment is frequently applied to treat skin afflictions and can also be useful in mitigating dermabrasion, prostate cancer, as well as pain."

Answered by AI

What is the numerical scope of individuals enrolled in this experiment?

"Affirmative. Evidence on clinicaltrials.gov suggests that this medical trial is still actively searching for participants, with 400 people needed from two locations since its first posting in November of 2019 and latest update in December of 2022."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Getting help an better. For the past two years I've been dealing with my pain getting worse. I can not remember a time before I was in pain, it been my normal since I was a child. It took me thirty minutes to realize when I had a broken elbow. Because it didn't feel that concerning at first. I'm also struggling with my mobilty due to fibromyalgia, and would like to be able to be more active again, go on hikes, not fall over constantly.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
2019. "Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03844412.
~74 spots leftby Apr 2025
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