A User Study With Vernivia® for Bacterial Vaginosis.

Not Applicable

Completed

• Conditions: Bacterial Vaginoses

• Registration Number: NCT06104098
• Lead Sponsor: Pharmiva AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-22
• Study First Submitted: 2021-09-02
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-27
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (7)

Mama Mia Väla; 🇸🇪 Väla, Helsingborg, 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