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Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

NCT04489290 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-10-26

No results posted yet for this study

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

DEVICE

D005 Vaginal Mousse

D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Key2Compliance

    collaborator INDUSTRY

  • CPS Research

    collaborator UNKNOWN

  • Scandinavian Development Services AB

    collaborator UNKNOWN

  • PepTonic Medical AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2023-10-04
Completion
2024-02-28

Countries

  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489290 on ClinicalTrials.gov