Clinical trials: Vulvar Disease
Vulvovaginal Candidiasis
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
- Trial name
- EpHect (NCT05507333)
- Testing
- pHyph generation II
- Where
- 4 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- Gedea Biotech AB
Prepubertal Labial Adhesions
Treatment of Prepubertal Labial Adhesions
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects.
- Trial name
- NCT02218463
- Testing
- Estradiol cream 0.01%, Cetaphil
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Children's Mercy Hospital Kansas City
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
Vaginitis, Infectious Vaginosis
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and…
- Trial name
- NCT01867164
- Testing
- Gynoclin V, Vagitrol V
- Where
- 2 sites in Mexico
- Volunteers
- 160 people
- Sponsor
- Janssen-Cilag, S.A.
Recurrent Vulvovaginal Candidiasis
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species…
- Trial name
- NCT02267382
- Testing
- VT-1161
- Where
- 32 sites in United States
- Volunteers
- 254 people
- Sponsor
- Viamet
Cervical Carcinoma, Malignant Female Reproductive System Neoplasm
Gynecological Sentinel Lymph Nodes CEUS
This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment).
- Conditions
- Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
- Trial name
- NCT05105087
- Testing
- Perflubutane Microbubble, Contrast-Enhanced Ultrasound
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Thomas Jefferson University
Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)
To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
- Trial name
- NCT00390013
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Colleen Stockdale
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Vulvovaginal Atrophy, Menopause
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Trial name
- REJOICE (NCT02253173)
- Testing
- Estradiol
- Where
- 105 sites in United States, Canada
- Volunteers
- 764 people
- Sponsor
- TherapeuticsMD
Postoperative Urinary Tract Infection, Laparoscopic Hysterectomy
Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections
This prospective observational study aims to evaluate whether additional vulvar re-antisepsis before intraoperative cystoscopy reduces the incidence of postoperative urinary tract infections (UTIs) in patients undergoing total…
- Conditions
- Postoperative Urinary Tract Infection, Laparoscopic Hysterectomy, Cystoscopy, Antisepsis
- Trial name
- NCT07232446
- Testing
- Additional Vulvar Re-Antisepsis Before Cystoscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people
- Sponsor
- Alaattin Karabulut
Vulvar and Vaginal Atrophy
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients…
- Trial name
- NCT03332303
- Testing
- Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
- Where
- 27 sites in United States
- Volunteers
- 540 people
- Sponsor
- Prasco LLC
Vulvovaginal Candidiasis, Candida Infection
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply…
- Conditions
- Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Trial name
- NCT06954493
- Testing
- Ibrexafungerp
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Scynexis, Inc.
Candidiasis, Vulvovaginal
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
- Trial name
- NCT02180828
- Testing
- Clotrimazole vaginal tablet, Fluconazole
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Peking University Shenzhen Hospital
Vulvovaginitis, Yeast Infection
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
- Conditions
- Vulvovaginitis, Yeast Infection, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
- Trial name
- NCT02971007
- Testing
- Oral Encochleated Amphotericin B (CAMB), Fluconazole
- Where
- 23 sites in United States
- Volunteers
- 137 people
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
Vulvar Lichen Sclerosus
Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
This study is being done to compare the effects, good and bad, of fractionated CO2 laser treatment and clobetasol propionate .05% ointment on vulvar lichen sclerosus.
- Trial name
- CuRLS (NCT02573883)
- Testing
- Fractionated Carbon Dioxide Laser, Clobetasol Propionate 0.05% ointment
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Medstar Health Research Institute
Vaginal Atrophy
Topical DHEA Against Vaginal Atrophy
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
- Trial name
- NCT01846442
- Testing
- DHEA (0.25%), DHEA (0.5%), DHEA (1.0%)
- Where
- 8 sites in United States, Canada
- Volunteers
- 218 people
- Sponsor
- EndoCeutics Inc.
Stage III Vulvar Cancer AJCC v7, Stage IIIA Vulvar Cancer AJCC v7
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby…
- Conditions
- Stage III Vulvar Cancer AJCC v7, Stage IIIA Vulvar Cancer AJCC v7, Stage IIIB Vulvar Cancer AJCC v7, Stage IIIC Vulvar Cancer AJCC v7
- Trial name
- NCT01595061
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy
- Where
- 193 sites in United States
- Volunteers
- 57 people
- Sponsor
- Gynecologic Oncology Group
Lichen Sclerosus
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks…
- Trial name
- NCT05593445
- Testing
- Ruxolitinib cream, Vehicle cream
- Where
- 14 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Incyte Corporation
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
Cervical Cancer, Genital Warts
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In…
- Trial name
- NCT00092521
- Testing
- V501, Human Papillomavirus (HPV) 16 Monovalent
- Volunteers
- 5,759 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC