Phase 4 N=28 Examining the Impact of Tampon Use on the Vaginal Microbiota
Vaginal Microbiota
Primary: Change in Relative Abundance of Lactobacillus Species — .0084; -.0014; -.00004; .0104 relative abundance
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=68 Rwanda Vaginal Microbiota Restoration Study
Bacterial Vaginosis
Primary: Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria — 7.53; 2.04; 3.36; 3.35 Incidence: events per PY at risk
Phase 4 N=25 Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
Female Urogenital Diseases · Vaginal Atrophy · Postmenopausal Atrophic Vaginitis
Primary: Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina — 0.07; 0.09; 0.12; 0.04 Relative abundance
Phase 1 N=12 Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Bacterial Vaginosis
Primary: Safety of LACTIN-V in Healthy Pre-menopausal Women. — 0; 0; 0; 0 participants
Phase 2 N=45 Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition
Bacterial Vaginosis · HIV Infections
Primary: Number of Participants With Genital Tract Inflammation — 3; 2 Participants
N/A N=54 Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Bacterial Vaginosis
Primary: Recurrent Bacterial Vaginosis — 7; 7 Participants — p=0.75
Phase 4 N=48 Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Candidiasis · Vaginosis, Bacterial
Primary: Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score. — 1.13; 1.21; 0.18; 0.22 score on a scale
Phase 4 N=81 Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Bacterial Vaginosis
Primary: Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests — 5.59; 5.22; 4.91; 7.41 log10 copies/ml — p=0.011
Phase 2 N=228 LACTIN-V Study for Recurrent Bacterial Vaginosis
Bacterial Vaginosis
Primary: The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm. — 0.11; 0.07 proportion of…
Phase 4 N=126 Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Participants With Related Clinical Signs or Symptoms at Baseline — 63; 63 Participants — p=<0.01
N/A N=482 Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Vaginal Microflora
Primary: Percentage of Subjects Showing Unfavorable Changes in Primary Microflora — 52.7; 52.9; 60.0 Percentage of Participants
Phase 3 N=251 A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 68; 25 Participants — p=<0.001
Phase 3 N=302 The Vaginal Health Trial
Atrophy of Vagina · Menopause · Dyspareunia (Female)
Primary: Most Bothersome Symptom (MBS) Severity — -1.2; -1.0; -0.2; -1.4 units on a scale — p=0.25
Phase 3 N=250 A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 59; 19 Participants — p=<0.001
Phase 2 N=234 Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Bacterial Vaginosis · Candidiasis · Trichomoniasis
Primary: Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights…
Phase 2 N=100 Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection
Urinary Tract Infection
Primary: Incidence of Urinary Tract Infection — 7; 13 participants
N/A N=24 Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
Bacterial Vaginosis
Primary: Clinical Cure Rate — 18 Participants
N/A N=35 Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue
Bacterial Vaginosis · Vaginal Discharge
Primary: p24 Antigen Production in Tissue
Phase 3 N=27 Lactobacillus Probiotic for Prevention of UTI
Urinary Tract Infections (UTI's)
Primary: UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group…
Phase 3 N=184 Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Patients With Bacterial Vaginosis at 3 Months — 15; 16 Participants
Phase 2 N=109 Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Participants With Clinical Cure in Each Study Arm — 11; 8 Participants — p=0.420
N/A N=27 The Estrogen Impact on Overactive Bladder Syndrome: Female Pelvic Floor Microbiomes and Antimicrobial Peptides
Overactive Bladder
Primary: Change in the Relative Abundance of Lactobacillus — 0.143 proportion of total microbes
Phase 3 N=160 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
Vaginitis · Infectious Vaginosis
Primary: Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment — 67.1; 79.2; 32.9; 20.8 Percentage of Participants
Phase 4 N=35 Investigation of the Effect of the Female Urinary Microbiome on Incontinence
Overactive Bladder · Incontinence · Nocturia
Primary: Change in the Relative Abundance of Lactobacillus — 0.275 proportion of total microbes
N/A N=351 Point of Care Diagnosis of Vaginal Infections
Vaginitis · Bacterial Vaginosis · Yeast Vaginitis
Primary: Number of Participants Prescribed Appropriate Treatment — 61; 104; 58; 21 Participants — p=<.001
Phase 3 N=1,365 Bacterial Vaginosis Home Screening to Prevent STDs
Bacterial Vaginosis
Primary: One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared…
Phase 1 N=16 Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Atrophic Vaginitis
Primary: Serum Concentrations of Estriol (E3) — 0; 0.91; 3.83; 1.58 pg/ml
Phase 1 N=105 Duration of Effect of Acidform Gel on Vaginal pH
Healthy
Primary: Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. — 4.85; 4.81; 4.91; 5.00 pH
Phase 2 N=24 Fermented Milk Drink on Human Intestinal Microflora
Signs and Symptoms, Digestive
Primary: Modification of the Composition of the Intestinal Microflora: Bifidobacterium — 7.88; 7.60; 8.13; 8.10 log10 CFU/g — p=<0.05
Phase 1 N=38 Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — 281.111; 257.194 ng/mL