Clinical trials: Vulva Disease
Sexual Pain Disorders, Postmenopausal Symptoms
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source…
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction
- Trial name
- NCT03682601
- Testing
- 5% sinecatechins ointment, 10% sinecatechins ointment
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GTO Pharmaceutical, LLC
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
Recurrent Vulvovaginal Candidiasis
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.
- Trial name
- ultraVIOLET (NCT03840616)
- Testing
- Oteseconazole (VT-1161) 150mg capsule, Fluconazole 150mg capsule
- Where
- 33 sites in United States
- Volunteers
- 219 people
- Sponsor
- Mycovia Pharmaceuticals Inc.
Vulvovaginal Atrophy, Dyspareunia
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks.
- Trial name
- NCT02784613
- Testing
- Ospemifene
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sue Goldstein
Advanced Solid Tumor, Lung Cancer
Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor
This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced…
- Conditions
- Advanced Solid Tumor, Lung Cancer, Pancreas Cancer, Breast Cancer
- Trial name
- CNSI-Fe(II) (NCT06048367)
- Testing
- CNSI-Fe(II) 30 mg, CNSI-Fe(II) 60 mg, CNSI-Fe(II) 90 mg
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Sichuan Enray Pharmaceutical Sciences Company
Cervical Cancer, Endometrial Cancer
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer
- Trial name
- NCT00381888
- Testing
- fondaparinux sodium
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Vulvovaginal Candidiasis
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic…
- Trial name
- NCT01144286
- Testing
- arasertaconazole nitrate
- Where
- Spain
- Volunteers
- 229 people
- Sponsor
- Ferrer Internacional S.A.
Vulvar Cancer
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing.
- Trial name
- NCT00504023
- Testing
- imiquimod, biopsy, therapeutic conventional surgery
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Bacterial Vaginosis, Candidiasis
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment.
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Trial name
- NCT01230814
- Testing
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
- Where
- 4 sites in United States, Kenya
- Volunteers
- 234 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Papillomavirus-16 Positive, Human Papillomavirus-18 Positive
DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
This phase II trial studies how well deoxyribonucleic acid (DNA) plasmid-encoding interleukin-12/human papillomavirus (HPV) DNA plasmids therapeutic vaccine INO-3112 and durvalumab work in treating patients with human…
- Conditions
- Human Papillomavirus-16 Positive, Human Papillomavirus-18 Positive, Metastatic Malignant Neoplasm, Recurrent Anal Canal Carcinoma
- Trial name
- NCT03439085
- Testing
- DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457, Durvalumab
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
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.
Lichen Sclerosus, Lichen Planus
Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.
- Conditions
- Lichen Sclerosus, Lichen Planus, Lichen Simplex Chronicus, Vulvodynia
- Trial name
- DATRIV (NCT02732145)
- Testing
- "Three Rings Vulvoscopy" (TRIV), Histopathology
- Where
- Croatia
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Ginekološka Poliklinika Dr. Vesna Harni
Vulvar Lichen Sclerosus
Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)
The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).
- Trial name
- Orchid 1 (NCT06132919)
- Testing
- MC2-25 cream, MC2-25 vehicle
- Where
- Denmark
- Volunteers
- 33 people
- Sponsor
- MC2 Therapeutics
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
Breast Cancer, Gynecologic Cancer
Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal…
- Trial name
- NCT01376349
- Testing
- prasterone
- Where
- 280 sites in United States
- Volunteers
- 464 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Invasive Candidiasis, Mucocutaneous Candidiasis
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or…
- Conditions
- Invasive Candidiasis, Mucocutaneous Candidiasis, Coccidioidomycosis, Histoplasmosis
- Trial name
- FURI (NCT03059992)
- Testing
- Ibrexafungerp
- Where
- 37 sites in United States, Austria and 6 more
- Volunteers
- 233 people
- Sponsor
- Scynexis, Inc.
Cervical Cancer, Uterine Cancer
Image-Guided Gynecologic Brachytherapy
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation.
- Conditions
- Cervical Cancer, Uterine Cancer, Vaginal Cancer, Carcinoma of the Vulva
- Trial name
- AMIGO (NCT01399658)
- Testing
- Image-guided brachytherapy, 3'-Deoxy-3'-18f-Fluorothymidine
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Dana-Farber Cancer Institute
Vulvovaginal Candidiasis
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
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 vulvovaginal candidias (VVC).
- Trial name
- NCT03761628
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB