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A User Study With Vernivia® for Bacterial Vaginosis.

NCT06104098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-10-31

No results posted yet for this study

Summary

This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material.

The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.

Conditions

  • Bacterial Vaginoses

Interventions

DEVICE

D005 vaginal mousse

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

Sponsors & Collaborators

  • Key2Compliance

    collaborator INDUSTRY

  • Replior AB

    collaborator UNKNOWN

  • PepTonic Medical AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-07-20
Completion
2021-07-22

Countries

  • Sweden

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 NCT06104098 on ClinicalTrials.gov