Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

Status Completed

Clinical Trial Summary

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed BV according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03762083
Study type	Interventional
Source	Gedea Biotech AB
Contact
Status	Completed
Phase	N/A
Start date	January 7, 2019
Completion date	November 18, 2019

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