A User Study With Vernivia® for Bacterial Vaginosis. (USV01)

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Device: D005 vaginal mousse

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58758
    • Mednika AB
  • Lomma, Sweden, 23439
    • Hälsomedicinskt Center
  • Malmö, Sweden, 21141
    • Mama Mia Barnmorskemottagning
  • Nyköping, Sweden, 61131
    • Kvinnohälsan Stadsfjärden
  • Stockholm, Sweden, 11435
    • 2Heal Medical
  • Sundsvall, Sweden, 85230
    • Ondrasek Läkarmottagning
  • Helsingborg
    • Väla, Helsingborg, Sweden, 25467
      • Mama Mia Väla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: D005 vaginal mousse; D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.; Other Names: Vernivia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Net Promotor Score regarding user-friendliness	Evaluate how the user experiences the user-friendliness (1 = Not likely, 10 = Very likely)	1-7 days
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
Clarity of instructional video	Evaluate how the user experiences the instructional video (1= Not at all informative, 5= Very informative)	1-7 days

Collaborators and Investigators

• Sponsor: Pharmiva AB
• Collaborators: Key2Compliance; Replior AB

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: USV01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No