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Phase II-b Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus Crispatus CTV-05 (LACTIN-V) to Prevent the Recurrence of Bacterial Vaginosis

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Trial Profile

Phase II-b Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus Crispatus CTV-05 (LACTIN-V) to Prevent the Recurrence of Bacterial Vaginosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 May 2022

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At a glance

  • Drugs CTV 05 (Primary) ; Metronidazole
  • Indications Bacterial vaginosis
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 15 Mar 2022 Results assessing short-term effect of standard Bacterial vaginosis treatment on genital immunology and the vaginal microbiota using participants recruited as part of this trial published in the Journal of Clinical Investigation
    • 14 May 2020 Primary endpoint has not been met. (The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm.)
    • 14 May 2020 Primary endpoint (The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.) has been met.
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