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NCT03844412 · ClinicalTrials.gov registry record · Phase 2
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 209
- Enrollment target
NCT03844412 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 209 participants.
The verdict
NCT03844412, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 209 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo pill
- DRUG Nortriptyline
- DRUG Placebo cream
- DRUG 5% lidocaine/5 mg/ml 0.02% estradiol compound cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2019-11-04 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03844412
The ClinicalTrials.gov registry entry for NCT03844412 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo pill is the first listed.
NCT03844412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03844412 about?
NCT03844412 is a clinical study titled "Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments". 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 th...
What is the current status of trial NCT03844412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 209 participants. The study started on 2019-11-04. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT03844412?
The interventions under investigation include: Placebo pill (DRUG), Nortriptyline (DRUG), Placebo cream (DRUG), 5% lidocaine/5 mg/ml 0.02% estradiol compound cream (DRUG).
Who is sponsoring clinical trial NCT03844412?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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