Clinical trials: Vulvar Diseases
Cervical Cancers, Vulvar Cancer
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and…
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions
- Trial name
- NCT00943722
- Testing
- V503
- Volunteers
- 3,074 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Vulvovaginal Candidiasis
The Study Of Fluconazole For Vulvovaginal Candidiasis
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas.
- Trial name
- NCT01806623
- Testing
- Fluconazole
- Where
- 10 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Pfizer
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- Vanish 306 (NCT03987620)
- Testing
- Ibrexafungerp
- Where
- 41 sites in United States, Bulgaria
- Volunteers
- 455 people
- Sponsor
- Scynexis, Inc.
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
Papillomavirus Infections
GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa.
- Trial name
- NCT01245764
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cervical Cancer, Vulvar Cancer
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and…
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
- Trial name
- NCT00543543
- Testing
- Comparator: GARDASIL, Experimental: V503
- Volunteers
- 14,840 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
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
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.
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
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.
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- NCT03734991
- Testing
- Ibrexafungerp
- Where
- 25 sites in United States
- Volunteers
- 376 people
- Sponsor
- Scynexis, Inc.
Human Papilloma Virus, Cervical Cancer
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX).
- Conditions
- Human Papilloma Virus, Cervical Cancer, Vulvar Cancer, Vaginal Cancer
- Trial name
- NCT00851643
- Testing
- Octavalent HPV with 15 mcg IMX / AAHS, Octavalent HPV with 30 mcg IMX / AAHS, Octavalent HPV with 60 mcg IMX / AAHS
- Volunteers
- 158 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.
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
Vulvovaginal Candidiasis
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of…
- Trial name
- NCT00803738
- Testing
- Terconazole Vaginal Suppository, Terazol Vaginal Suppository
- Volunteers
- 572 people
- Sponsor
- Padagis LLC
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Recurrent Vulvovaginal Candidiasis
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months.
- Trial name
- VIOLET (NCT03561701)
- Testing
- Oteseconazole (VT-1161)
- Where
- 14 sites in United States
- Volunteers
- 425 people
- Sponsor
- Mycovia Pharmaceuticals Inc.
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