A User Study With Vernivia® for Bacterial Vaginosis.

A User Study With Vernivia® for Bacterial Vaginosis (USV01) Evaluation of User-friendliness, Measure Time From the Start of Treatment to Symptom Relief and the Clarity of Instructional Material

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06104098

Acronym

USV01

Enrollment

Registered

2023-10-27

Start date

2021-04-01

Completion date

2021-07-22

Last updated

2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginoses

Brief 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.

Interventions

DEVICED005 vaginal mousse

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 49 Years

Healthy volunteers

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

Exclusion criteria

* Symptoms of vaginal candida infection and/or Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Evaluate symptom relief during treatment with Vernivia®.	1-7 days	Evaluation of number of days from start of treatment until symptom relief

Secondary

Measure	Time frame	Description
Self-reported grading of malodorous discharge (0-3)	1-7 days	Evaluate how the user experiences the product with regards to malodorous (1 = Not likely, 10 = Very likely)
Net Promotor Score regarding user-friendliness	1-7 days	Evaluate how the user experiences the user-friendliness (1 = Not likely, 10 = Very likely)
Clarity of the IFU (Instructions For Use)	1-7 days	Evaluate how the user experiences the IFU (Instructions For Use) (1= Not at all informative, 5= Very informative)
Clarity of instructional video	1-7 days	Evaluate how the user experiences the instructional video (1= Not at all informative, 5= Very informative)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026