Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Duke University.
NCT03844412 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 209 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03844412 record still lists
NCT03844412 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo pill is the first listed.
NCT03844412 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03844412's enrollment target sits among peer trials
209 294th of 2000 higher than 1,707 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04742634 · 209 participants · Phase 1
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
- NCT07214688 · 209 participants · Phase 2
Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
- NCT02665923 · 210 participants
Gastric Emptying in Neonates and Infants After Formula Feeding
- NCT03322891 · 210 participants · NA
Improving Health Literacy in African-American Prostate Cancer Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI