Clinical Trial Search

Primary: Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights…

Primary: Number of Participants Prescribed Appropriate Treatment — 61; 104; 58; 21 Participants — p=<.001

Primary: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit — 47; 25 Participants — p=0.002

Primary: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit — 47; 18 Participants — p=<0.001

Primary: Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit — 31; 29; 43 Participants — p=0.030

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

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

Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 68; 25 Participants — p=<0.001

Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 59; 19 Participants — p=<0.001

Primary: Recurrent Bacterial Vaginosis — 7; 7 Participants — p=0.75

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…

Primary: Number of Participants With the Same Gynaecological Conditions at the End of Treatment Visit — 13 Participants

Primary: p24 Antigen Production in Tissue

Primary: Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population — 9; 9; 11; 10 Participants

Primary: Percentage of Participants Cured of Vaginal Trichmonas — 90; 90; 88 percentage of participants

Primary: Most Bothersome Symptom (MBS) Severity — -1.2; -1.0; -0.2; -1.4 units on a scale — p=0.25

Primary: The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. — 2; 3; 0; 2 Participants

Primary: Incidence of Urinary Tract Infection — 7; 13 participants

Primary: Clinical Cure Rate — 18 Participants

Primary: Safety of LACTIN-V in Healthy Pre-menopausal Women. — 0; 0; 0; 0 participants

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…

Primary: Number of Patients With Bacterial Vaginosis at 3 Months — 15; 16 Participants

Primary: Clinical Cure Rate at Day 7-14 — 10; 16 Participants

Primary: Number of Participants With Clinical Cure in Each Study Arm — 11; 8 Participants — p=0.420

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

Primary: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. — 3.9; 39.4…

Primary: Change in Relative Abundance of Lactobacillus Species — .0084; -.0014; -.00004; .0104 relative abundance

Primary: Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) — 58; 34 Participants

Primary: Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population — 6.7; 42.8…

Primary: Occurrence of UTI During Randomization — 8; 10 Participants