Clinical trials: Vulvar Diseases
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
Menopause, Vulvovaginal Atrophy
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and…
- Conditions
- Menopause, Vulvovaginal Atrophy, Painful Intercourse, Dyspareunia
- Trial name
- NCT02449902
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- TherapeuticsMD
Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth
Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
This cohort study plans to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.
- Conditions
- Sexually Transmitted Infections (Not HIV or Hepatitis), Premature Birth, Pregnancy; Infection, Microbial Colonization
- Trial name
- NCT06131749
- Testing
- No intervention
- Where
- South Africa
- Volunteers
- 603 people
- Sponsor
- University of Bern
Vulvar Cancer
Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy
The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.
- Trial name
- GroSNaPET (NCT02969278)
- Testing
- 18FDG-PET/TC, Sentinel node biopsy
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Catholic University of the Sacred Heart
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
Vulvar Cancers, Vulva Neoplasm
Needlefree Lidocaine Application for Vulvar Biopsies
The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot.
- Conditions
- Vulvar Cancers, Vulva Neoplasm, Vulvar Dysplasia
- Trial name
- NCT07793552
- Testing
- J-Tip, Lidocaine HCl 1%
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Tufts Medical Center
Vestibulodynia, Vulvodynia
Savella in Treatment for Provoked Vestibulodynia
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe…
- Trial name
- NCT01304589
- Testing
- Milnacipran
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
Vestibulodynia
Lipofilling as a Treatment for Vestibulodynia
The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than…
- Trial name
- NCT03431779
- Testing
- Adipose derived stem cell transplantation via lipofilling, Surgical excision
- Where
- Belgium
- Volunteers
- 9 people
- Sponsor
- University Hospital, Ghent
Anxiety Disorder, Cervical Cancer
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with…
- Conditions
- Anxiety Disorder, Cervical Cancer, Endometrial Cancer, Female Reproductive Cancer
- Trial name
- NCT02096783
- Testing
- informational intervention, counseling intervention, questionnaire administration
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Wisconsin, Madison
Vaginal Infection, ASC-US
Probiotic Implementation as Help in Solving Vaginal Infections
Over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being.
- Trial name
- NCT03372395
- Testing
- Lactobacillus rhamnosus BMX 54
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- University of Roma La Sapienza
Vulvar Mucosa Lesions, Vulvar Intraepithelial Neoplasia
Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin.
- Trial name
- NCT02735109
- Testing
- photographies, biopsy normal area
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Head and Neck Cancers, Lung and Esophagus Cancers
Adaptive Pet Study
The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment.
- Conditions
- Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
- Trial name
- NCT01908504
- Testing
- PET-CT
- Where
- United States
- Volunteers
- 271 people
- Sponsor
- Duke University
Bacterial Vaginosis, Candida Albicans Vulvovaginitis
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
- Conditions
- Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis, Trichomonas Vaginitis
- Trial name
- NCT04219605
- Where
- Israel
- Volunteers
- 226 people
- Sponsor
- Meir Medical Center
Vaginitis, Bacterial Vaginosis
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora.
- Trial name
- NCT05652959
- Testing
- Cerviron®
- Where
- 10 sites in Romania
- Volunteers
- 111 people
- Sponsor
- Perfect Care Distribution
Cervical Cancer, Vulvar Cancer
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4…
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
- Trial name
- NCT03158220
- Testing
- V503
- Where
- 24 sites in Austria, Belgium and 4 more
- Volunteers
- 1,212 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Candida Vulvovaginitis
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and…
- Trial name
- DOVE (NCT03253094)
- Testing
- Fluconazole, SCY-078
- Where
- 25 sites in United States
- Volunteers
- 186 people
- Sponsor
- Scynexis, Inc.
Microbiome, Antibiotic-Induced VVC
Study of Antibiotic-induced Vaginal Yeast Infections in Healthy Women
Background: Vaginal yeast infections are caused by a fungus called Candida. Candida can live harmlessly in the vagina, but most women will have symptoms from a vaginal yeast infection at some point during their life.
- Conditions
- Microbiome, Antibiotic-Induced VVC, Vaginal Candidiasis
- Trial name
- NCT01915251
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ovarian Neoplasms, Endometrial Neoplasms
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Cancer
- Trial name
- DOVE (NCT06023862)
- Testing
- Dostarlimab, Bevacizumab, Doxorubicin
- Where
- 27 sites in Australia, Hong Kong and 5 more
- Volunteers
- 198 people
- Sponsor
- Yonsei University
Vulvar Cancer
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials.
- Trial name
- STRIVE (NCT05576831)
- Testing
- Re-excision
- Where
- Canada
- Volunteers
- 249 people
- Sponsor
- British Columbia Cancer Agency
Ovarian Carcinoma, Cervical Carcinoma
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
Multicenter ambispective observational study (prospective/retrospective)
- Conditions
- Ovarian Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Vulvar Carcinoma
- Trial name
- NCT07267780
- Where
- 2 sites in Italy
- Volunteers
- 130 people
- Sponsor
- National Cancer Institute, Naples