Clinical trials: Vulvar Disease
Vulvar Cancer
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer.
- Trial name
- NCT06127836
- Testing
- ICG guided sentinel lymph node biopsy
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Vulvar Intraepithelial Neoplasia, Genital Warts
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
This pilot clinical study is to evaluate the efficacy \& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
- Trial name
- NCT01676792
- Testing
- SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
- Where
- Taiwan
- Volunteers
- 29 people
- Sponsor
- National Cheng-Kung University Hospital
Vaginitis, Bacterial Vaginosis
Point of Care Diagnosis of Vaginal Infections
Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and…
- Conditions
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
- Trial name
- PAT (NCT06438575)
- Testing
- Xpert® Xpress MVP test, Usual Care
- Where
- United States
- Volunteers
- 351 people
- Sponsor
- Sharon L Hillier
Vulvar Cancer Stage I, Vulvar Cancer Stage II
A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive…
- Conditions
- Vulvar Cancer Stage I, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node
- Trial name
- ANVU (NCT06476639)
- Testing
- High-resolution bilateral groin ultrasound monitoring
- Where
- 9 sites in Australia
- Volunteers
- 640 people
- Sponsor
- Queensland Centre for Gynaecological Cancer
Recurrent Vulvovaginal Candidiasis
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis.
- Trial name
- NCT04639544
- Testing
- Lactobacillus strain
- Where
- Spain
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Any Condition Requiring Vulvar Biopsy
Pain Perception During Vulvar Biopsy
The purpose of this study is to compare pain control during vulvar biopsy following either (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and prilocaine 2.5%) cream or (2) injection of 1%…
- Trial name
- NCT03654417
- Testing
- EMLA, Lidocaine
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Duke University
Cervical Cancer, Vulvar Cancer
Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers…
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
- Trial name
- NCT02653118
- Testing
- V503, GARDASIL
- Volunteers
- 4,453 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Vulvodynia
Vulvodynia Pain Thresholds
Annotated pain maps will be created showing region and size of areas sensitive to mechanical stimulus in both women affected by vulvar pain and unaffected control patients.
- Trial name
- NCT04461210
- Testing
- Thermographic Imaging and Mechanical Pain Assessment
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Vulvar Lichen Sclerosus
Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus
Vulvar lichen sclerosus (LS) is a chronic inflammatory disease, often diagnosed at late stages after scarring has obliterated normal vulvar architecture and severely affected a woman's quality of life.
- Trial name
- NCT05147129
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Texas Southwestern Medical Center
Healthy, Vulvodynia
Pelvic Floor Myofascia: A New Player Involved in Vulvodynia
This study aims to develop novel ultrasound evaluation techniques to characterize the different pelvic myofascial tissues and to examine the intra- and inter-rater reliability of these techniques (objective 1).
- Trial name
- NCT05350618
- Testing
- Ultrasound evaluation
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Université de Sherbrooke
Vulvar Cancer
AK104 for Recurrent or Metastatic Vulvar Cancer
This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent…
- Trial name
- NCT05932212
- Testing
- AK104, AK104+ Paclitaxel+Cisplatin or Carboplatin
- Where
- 6 sites in China
- Volunteers
- 20 people
- Sponsor
- Akeso
Gynaecological Cancers, Ovarian Cancer
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
The goal of the MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial…
- Conditions
- Gynaecological Cancers, Ovarian Cancer, Endometrial Cancer, Vulvar Cancer
- Trial name
- MYSSELF (NCT07902375)
- Testing
- Colli-Pee 20 mL device with UCM, Evalyn Brush
- Where
- Belgium
- Volunteers
- 730 people
- Sponsor
- Universiteit Antwerpen
Vulvodynia
Dysport in Vulvodynia Phase II Study
This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.
- Trial name
- DYVINIA (NCT03598777)
- Testing
- Botulinum toxin type A
- Where
- 9 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Ipsen
Provoked Localized Vulvodynia
Remote Mindfulness Education PLV
This is a study designed to learn more about the use of an online remote education and mindfulness practice program for the pain and anxiety associated with provoked localized vulvodynia.
- Trial name
- NCT03541512
- Testing
- Mindfulness + Education, Education
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Oregon Health and Science University
Vulvar Cancers
A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER
This is a phase II, randomized study that will include 42 participants who have received 4 to 6 cycles of first-line platinum-based chemotherapy for advanced vulvar squamous cell carcinoma (SCC) not amenable to curative surgical…
- Trial name
- BRAVA VULVAR (NCT07101848)
- Testing
- Cemiplimab
- Where
- Brazil
- Volunteers
- 42 people
- Sponsor
- Hospital Israelita Albert Einstein
Vulvodynia, Dyspareunia
Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
We are looking to see if patients using both topical testosterone and estrogen will have a greater improvement in pain with vaginal penetration compared to those using topical estrogen alone.
- Conditions
- Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva
- Trial name
- NCT07260825
- Testing
- Estradiol 0.01% Vag Cream, testosterone 0.1% and estradiol 0.01% vaginal cream
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- TriHealth Inc.
Rectovaginal Fistula, Crohn Disease
Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease
Approximately 10% of all female Crohn's patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished…
- Conditions
- Rectovaginal Fistula, Crohn Disease, Crohn Disease of Vulva, Rectolabial; Fistula
- Trial name
- RVF (NCT04519697)
- Testing
- Mesenchymal Stem Cells
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Anthony Lembo
Vulvar Lichen Sclerosus
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur.
- Trial name
- NCT00757874
- Testing
- Tacrolimus cream, Clobetasol cream
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Deana Funaro
Vulva Cancer, Sentinel Lymph Node
Sentinel Node Extended in Squamous Cell Vulvar Cancer
The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e.
- Trial name
- SNEX (NCT04147780)
- Testing
- Sentinel node biopsy
- Where
- 4 sites in Sweden
- Volunteers
- 64 people
- Sponsor
- Diana Zach
Ovarian Cancer, Endometrial Cancer
GYNecologic Cancer-Related COGnitive Impairment
The goal of this study is to test a home-based and patient-tailored cognitive training intervention among gynecologic cancer patients who have completed chemotherapy and who have experienced cancer-related cognitive impairment.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancers, Vulvar Cancers
- Trial name
- GYNCOG (NCT06662435)
- Testing
- GYNCOG
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Northwestern University