Clinical trials: Vulvar Disease
Vaginal Atrophy
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.
Vulvodynia
CC-10004 For The Treatment Of Vulvodynia
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors.
- Trial name
- NCT00814632
- Testing
- CC-10004
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Kenneth Peters, MD
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
Fallopian Tube Cancer, Ovarian Cancer
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer
- Trial name
- NCT00870233
- Testing
- online platform WEBCORE
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Vulvar Lichen Sclerosus
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
- Trial name
- NCT05243563
- Testing
- MonaLisa Touch, Topical steroid
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of South Alabama
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
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
HPV Positive Cancer, Vulvar, Vaginal, Penile, Rectal Cancer
HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on…
- Conditions
- HPV Positive Cancer, Vulvar, Vaginal, Penile, Rectal Cancer, Anal Cancer, Oropharyngeal Cancer
- Trial name
- NCT04432597
- Testing
- PRGN-2009, M7824, EKG
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- National Cancer Institute (NCI)
Vaginitis and Vulvovaginitis
Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis.
- Trial name
- NCT04735705
- Testing
- Cerviron
- Where
- 2 sites in Romania
- Volunteers
- 50 people
- Sponsor
- Perfect Care Distribution
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
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
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
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
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.
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