Clinical trials: Vaginal Disease
Fecal Incontinence
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
- Trial name
- LIFE (NCT01655498)
- Testing
- vaginal bowel control system (LivSure)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Pelvalon, Inc.
Candidiasis, Vulvovaginal
Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered…
- Trial name
- GYNOCANS (NCT02251093)
- Testing
- Lcr Regenerans
- Where
- France
- Volunteers
- 350 people
- Sponsor
- Probionov
Bacterial Vaginosis
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
- Trial name
- NCT01201057
- Testing
- 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, 3.0% SPL7013 Gel
- Where
- 5 sites in United States
- Volunteers
- 132 people
- Sponsor
- Starpharma Pty Ltd
Head and Neck Cancer, Cervical Cancer
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived engeneered T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens…
- Conditions
- Head and Neck Cancer, Cervical Cancer, Non-small Cell Carcinoma, Melanoma
- Trial name
- NCT05973487
- Testing
- TSC-204-A0201, TSC-204-C0702, TSC-200-A0201
- Where
- 21 sites in United States
- Volunteers
- 840 people
- Sponsor
- TScan Therapeutics, Inc.
Vaginal Infection
Multi-Center Study of New Medications to Treat Vaginal Infections
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
- Trial name
- SMART GIVES (NCT02308033)
- Testing
- Metronidazole, Gel vehicle
- Where
- 35 sites in United States
- Volunteers
- 204 people
- Sponsor
- Curatek Pharmaceuticals, LLC
HIV Infections, HSV-2 Genital Herpes
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013…
- Trial name
- NCT00740584
- Testing
- 3% SPL7013 Gel (VivaGel)
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Starpharma Pty Ltd
Vaginal Disease
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.
- Trial name
- NCT04245358
- Testing
- Ainara
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Italfarmaco
Endometriosis
Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy
A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal applications of single dose of VML-0501 (100 mg…
- Trial name
- NCT03352076
- Testing
- Vaginal Danazol, Oral Danatrol
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Viramal Limited
Recurrent Vulvovaginal Candidiasis
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis
- Trial name
- NCT05074602
- Testing
- SHR8008, Fluconazole
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HIV Infections
Trial of SAVVY Vaginal Gel and HIV in Nigeria
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of…
- Trial name
- NCT00130078
- Testing
- 1.0% C31G SAVVY vaginal gel
- Where
- 2 sites in Nigeria
- Volunteers
- 2,142 people, healthy volunteers welcome
- Sponsor
- Biosyn
Atrophy, Vaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
- Trial name
- NCT01585558
- Testing
- Ospemifene (Dose 1), Ospemifene (Dose 2)
- Volunteers
- 180 people
- Sponsor
- Shionogi
Bacterial Vaginosis, Vulvovaginal Candidiasis
TOL-463 Phase 2 Study for Vaginitis
This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.
- Trial name
- NCT02866227
- Testing
- TOL-463
- Where
- 2 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Toltec Pharmaceuticals, LLC
Luteal Hormone Supplementation in In-vitro Fertilization, Embryo Transfer
Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan…
- Trial name
- NCT01863680
- Testing
- COL-1620, Gonadotropin-releasing hormone (GnRH) analogue, Follicle-stimulating hormone (FSH)
- Where
- 5 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Premature Ejaculation
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline…
- Trial name
- NCT01184105
- Testing
- Intervention A, Intervention B
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Plethora Solutions Ltd
Vulvovaginal Candidiases, Vulvovaginal Candidiasis, Genital
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
- Conditions
- Vulvovaginal Candidiases, Vulvovaginal Candidiasis, Genital, Vulvovaginal Candidiasis (VVC)
- Trial name
- NCT07109869
- Testing
- Boric acid
- Where
- 26 sites in United States
- Volunteers
- 333 people
- Sponsor
- pH-D Feminine Health LLC
Bacterial Vaginosis
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
- Trial name
- NCT07302035
- Testing
- GenSci142
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Bacterial Vaginosis
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
- Trial name
- NCT02237950
- Testing
- Metronidazole oral tablets 500mg, 1% SPL7013 Gel
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 586 people
- Sponsor
- Starpharma Pty Ltd
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
Irritable Bowel Syndrome, Vaginal Health
A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
- Trial name
- NCT06124313
- Testing
- Vaginal Probiotic
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Rael
Vaginal Odor
The Effects of an Orally-Administered Probiotic on Vaginal Symptoms
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms.
- Trial name
- NCT07829861
- Testing
- Orally-administered probiotic
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Bonafide Health