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

Pharmiva

Status: Completed

Conditions: Bacterial Vaginoses

Treatments: Device: D005 vaginal mousse

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06104098

USV01

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

One dose daily for 7 consequtive days (dose acc to IFU)

Other group

Description:

Open user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use.

Treatment:

Device: D005 vaginal mousse