A User Study With Vernivia® for Bacterial Vaginosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-07-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Vaginoses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One dose daily for 7 consequtive days (dose acc to IFU)

Open user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use.

Group Type OTHER

D005 vaginal mousse

Intervention Type DEVICE

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

Interventions

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D005 vaginal mousse

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

Intervention Type DEVICE

Other Intervention Names

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Vernivia

Eligibility Criteria

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Inclusion Criteria

* Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone