Vulvar Diseases

6

Review clinical trials related to Vulvar Diseases. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Large Algorithm Setting and Validation Study

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Nanopath, IncUpdated: May 26, 2026Locations: 1
Eligibility criteria

Abnormal vaginal discharge [+4]

Participants who do not meet the above-described inclusion criteria will be excl... [+2]

Status: Recruiting

Danish Vulva Cancer Recurrence Study

The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs. DaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses. Total number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022. Hypotheses: * All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis. * Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC. * Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.

Participants needed: 1,295
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of AarhusUpdated: Apr 29, 2026Locations: 2
Eligibility criteria

Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva [+2]

Active treatment for concurrent cancer and/or dissemination of concurrent cancer

Status: Recruiting

Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

Primary: * To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision * To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Participants needed: 91
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of VirginiaUpdated: Oct 20, 2025Locations: 1
Eligibility criteria

Must be 18 years of age [+3]

Unable to give informed consent [+9]

Status: Recruiting

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Participants needed: 27
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Frantz Viral Therapeutics, LLCUpdated: Aug 14, 2025Locations: 5
Eligibility criteria

Adult women age ≥ 18 years [+10]

Pregnant and nursing women [+10]

Status: Recruiting

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Participants needed: 365
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Marengo Therapeutics, Inc.Updated: Jul 9, 2025Locations: 32
Eligibility criteria

Participants must have histologically confirmed solid tumors that are unresectab... [+14]

Vitiligo; [+16]

Status: Recruiting

Vulvar Disease in Nigeria Observational Study

Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria

Participants needed: 1,000
Trial details
Age: 10-90Biological sex: FemaleType: ObservationalSponsor: KDRS ltdUpdated: Jun 6, 2023Locations: 1Duration: 12 Months
Eligibility criteria

biological females - afab

none-afab