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OpenTrials
Completed

NCT Number: NCT06104098

A User Study With Vernivia® for Bacterial Vaginosis.

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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Key information

Conditions

Bacterial Vaginoses Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

16 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mama Mia Väla, Väla, Helsingborg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D005 vaginal mousse

Device

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

Other names: Vernivia

Primary outcomes

  1. Evaluate symptom relief during treatment with Vernivia®.

    Time frame: 1-7 days

    Evaluation of number of days from start of treatment until symptom relief

Secondary outcomes

  1. Self-reported grading of malodorous discharge (0-3)

    Time frame: 1-7 days

    Evaluate how the user experiences the product with regards to malodorous

    (1 = Not likely, 10 = Very likely)

  2. Net Promotor Score regarding user-friendliness

    Time frame: 1-7 days

    Evaluate how the user experiences the user-friendliness

    (1 = Not likely, 10 = Very likely)

  3. Clarity of the IFU (Instructions For Use)

    Time frame: 1-7 days

    Evaluate how the user experiences the IFU (Instructions For Use)

    (1= Not at all informative, 5= Very informative)

  4. Clarity of instructional video

    Time frame: 1-7 days

    Evaluate how the user experiences the instructional video

    (1= Not at all informative, 5= Very informative)

Sponsors and collaborators

Lead sponsor

PepTonic Medical AB

Industry

Collaborators

  • Key2Compliance
  • Replior AB

Registry information

Official study 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

Acronym: USV01

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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