Bacterial VaginosesUSV01NCT06104098
A User Study With Vernivia® for Bacterial Vaginosis.
A study testing D005 vaginal mousse in people with Bacterial Vaginoses, run by PepTonic Medical AB at 7 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- D005 vaginal mousse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 7 sitesSweden
- Study dates
- 1 Apr 2021to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Symptoms of vaginal candida infection and/or Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Mednika AB
Linköping, 58758
Hälsomedicinskt Center
Lomma, 23439
Mama Mia Barnmorskemottagning
Malmö, 21141
Kvinnohälsan Stadsfjärden
Nyköping, 61131
2Heal Medical
Stockholm, 11435
Ondrasek Läkarmottagning
Sundsvall, 85230
Mama Mia Väla
Väla, Helsingborg, 25467
About this study
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
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.
- Conditions
- Bacterial Vaginoses
- Being tested
- D005 vaginal mousse
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D005 vaginal mousseDevice
Also called Vernivia
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
| Study group | Role | What they receive |
|---|---|---|
| One dose daily for 7 consequtive days (dose acc to IFU) | Other | Open user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use. Receives: Device: D005 vaginal mousse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate symptom relief during treatment with Vernivia®.
Evaluation of number of days from start of treatment until symptom relief
Measured: 1-7 days
Secondary outcomes (4)
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)
Measured: 1-7 days
Net Promotor Score regarding user-friendliness
Evaluate how the user experiences the user-friendliness
(1 = Not likely, 10 = Very likely)
Measured: 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)
Measured: 1-7 days
Clarity of instructional video
Evaluate how the user experiences the instructional video
(1= Not at all informative, 5= Very informative)
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Apr 2021
- Primary completion20 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, Replior AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104098
- Sponsor's protocol ID
- USV01
- Acronym
- USV01
- Status last verified
- Oct 2023
- First submitted
- 2 Sep 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06104098
- Acronym / sponsor ID
- USV01 / USV01
- Conditions
- Bacterial Vaginoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, Replior AB
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One dose daily for 7 consequtive days (dose acc to IFU) | Other | Device: D005 vaginal mousseOpen user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Symptoms of vaginal candida infection and/or Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D005 vaginal mousseAlso: VerniviaD005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis. | Device | One dose daily for 7 consequtive days (dose acc to IFU) |
Primary outcome
Evaluate symptom relief during treatment with Vernivia®.
Time frame: 1-7 days
Evaluation of number of days from start of treatment until symptom relief
4 secondary outcomes
Self-reported grading of malodorous discharge (0-3)
Time frame: 1-7 days
Net Promotor Score regarding user-friendliness
Time frame: 1-7 days
Clarity of the IFU (Instructions For Use)
Time frame: 1-7 days
Clarity of instructional video
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginoses
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D005 vaginal mousse in people with Bacterial Vaginoses, run by PepTonic Medical AB at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate symptom relief during treatment with Vernivia®. (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.