A User Study With Vernivia® for Bacterial Vaginosis.

Bacterial Vaginoses Clinical Trial

— USV01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06104098
• Other study ID #: USV01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 22, 2021

Study information

• Verified date: October 2023
• Source: Pharmiva AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 22, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Device:
• D005 vaginal mousse
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

Locations

Country	Name	City	State
Sweden	Mednika AB	Linköping
Sweden	Hälsomedicinskt Center	Lomma
Sweden	Mama Mia Barnmorskemottagning	Malmö
Sweden	Kvinnohälsan Stadsfjärden	Nyköping
Sweden	2Heal Medical	Stockholm
Sweden	Ondrasek Läkarmottagning	Sundsvall
Sweden	Mama Mia Väla	Väla	Helsingborg

Sponsors (3)

Lead Sponsor	Collaborator
Pharmiva AB	Key2Compliance, Replior AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate symptom relief during treatment with Vernivia®.	Evaluation of number of days from start of treatment until symptom relief	1-7 days
Secondary	Self-reported grading of malodorous discharge (0-3)	Evaluate how the user experiences the product with regards to malodorous; (1 = Not likely, 10 = Very likely)	1-7 days
Secondary	Net Promotor Score regarding user-friendliness	Evaluate how the user experiences the user-friendliness; (1 = Not likely, 10 = Very likely)	1-7 days
Secondary	Clarity of the IFU (Instructions For Use)	Evaluate how the user experiences the IFU (Instructions For Use); (1= Not at all informative, 5= Very informative)	1-7 days
Secondary	Clarity of instructional video	Evaluate how the user experiences the instructional video; (1= Not at all informative, 5= Very informative)	1-7 days