NCT03844412CompletedPhase 2
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 209 (actual)
- First submitted
- 15 Feb 2019
- Start date
- 4 Nov 2019
- Primary completion date
- 13 Mar 2024
- Lead sponsor
- Duke University
- Diseases
- Migraine, Endometriosis, Long COVID and ME/CFS
- NCT number
- NCT03844412
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 209
- From 4 Nov 2019 to the primary completion date, 13 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of nortriptyline or other TCA medications within the past three months
- Previous vestibulectomy
- Chemotherapy and/or radiation treatment within the past year.
- Use of immunosuppressant medications
- Contraindications to the use of topical estrogen therapy
- Post-menopausal, defined as no menses for 12 consecutive months or surgical removal of both ovaries. (Hysterectomy is not an exclusion)
- Are not currently receiving pelvic physical therapy
Other illness
- Presence of active dermatologic vulvar disease or vaginal infection
- Untreated atrophic vaginitis (participants may undergo treatment and re-evaluation for enrollment if the condition is resolved)
- Cancer within the past year.
- Unstable medical condition (e.g., renal impairment, significant hematological disease, cardiovascular disease, hepatic insufficiency, neurological disorder, autoimmune disease, or respiratory illness)
- History of intolerance to nortriptyline, topical lidocaine, or topical estradiol
- Contraindications to use of nortriptyline: current use, or use within the past 3 months, of MAOIs, SSRIs, SNRIs, NDRIs; recent (within the past year) myocardial infarction, active psychotic or suicidal thoughts, narrow angle closure glaucoma
Other
- Use of daily topical lidocaine, or estradiol, or lidocaine/estradiol to the vulvar vestibule within the past three months
- Use of pregabalin or gabapentin within the past three months
- Pregnant or planning on becoming pregnant during the study period. Within the first six months of the postpartum period. Currently breastfeeding/lactating, or within three months of discontinuing breastfeeding/lactation.
- Active incarceration
- Clear inflammatory states (e.g., morbid obesity)
- Contraindications to the use of lidocaine or local anesthetics
- Have not had Botox of the pelvic floor muscles in the last 12 months, or pelvic nerve blocks in the last three months.
- Are not currently enrolled or planning to enroll in another clinical trial during the course of this trial.
Who the study is looking for
- Female
- Age 18-50 years
- English-literate
- Willingness to provide informed consent
- Meeting criteria for diagnosis of VBD based on:
- self-report of 3 continuous months of insertional (entryway) dyspareunia, and/or pain to touch/tampon insertion
- pain score of ≥ 3 on the tampon insertion test
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.