NCT04489290

Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms, and the Vaginal Environment in Patients With Bacterial Vaginosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: PepTonic Medical AB · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis. The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.

Conditions

• Bacterial Vaginosis | Vaginal | Microbiology

Interventions

Type	Name	Description
DEVICE	D005 Vaginal Mousse	D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-02-12
• Primary completion: 2023-10-04
• Completion: 2024-02-28
• First posted: 2020-07-28
• Last updated: 2023-10-26

Locations

9 sites across 2 countries: Sweden, United Kingdom