Clinical trials: Vulvar Disease
Vulvovaginal Candidiasis
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A…
- Trial name
- NCT01926028
- Testing
- NDV-3A, NDV-3
- Where
- 20 sites in United States
- Volunteers
- 188 people
- Sponsor
- NovaDigm Therapeutics, Inc.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
- Trial name
- NCT00276094
- Testing
- Ospemifene 30 mg, Ospemifene 60 mg, Nonhormonal vaginal lubricant
- Volunteers
- 826 people
- Sponsor
- Shionogi
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.
Advanced Solid Tumors
A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors
This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib.
- Trial name
- NCT05949632
- Testing
- INCB099280, axitinib
- Where
- 6 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Incyte Corporation
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
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
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
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
Candidiasis, Vulvovaginal
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection).
- Trial name
- NCT01891331
- Testing
- VT-1161, Fluconazole
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Viamet
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 Cancers, Vulvar Cancers
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™.
- Conditions
- Cervical Cancers, Vulvar Cancers, Vaginal Cancers, Genital Warts
- Trial name
- NCT01047345
- Testing
- V503
- Volunteers
- 924 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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.
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
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
Vulvar Lichen Sclerosus
The CO2RE® System for Vulvar Lichen Sclerosus
Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS…
- Trial name
- NCT04148651
- Testing
- The CO2RE® System
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Candela Corporation
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Safety of Ospemifene
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
- Trial name
- NCT00566982
- Testing
- Ospemifene 60 mg
- Volunteers
- 426 people
- Sponsor
- Shionogi
Dyspareunia
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
- Trial name
- NCT05617820
- Testing
- Estradiol, Imvexxy
- Where
- 48 sites in United States, El Salvador and 1 more
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Atrophic Vaginitis
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02195986
- Testing
- Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream
- Where
- 21 sites in United States
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg…
- Trial name
- NCT00630539
- Testing
- Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
- Volunteers
- 126 people
- Sponsor
- Shionogi
Vaginal Atrophy
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01358760
- Testing
- DHEA
- Where
- 42 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- EndoCeutics Inc.