Bacterial Vaginosis | Vaginal | MicrobiologyNCT04489290
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
A study testing D005 Vaginal Mousse in people with Bacterial Vaginosis | Vaginal | Microbiology, run by PepTonic Medical AB at 9 sites in 2 countries.
Trial summary
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis. The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Bacterial Vaginosis | Vaginal | Microbiology
- What is being tested?
- D005 Vaginal Mousse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Feb 2021to 28 Feb 2024
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willingness and ability to provide informed consent
- Female in fertile age
- Age ≥18 years
- Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
- A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
- Presence of clue cells (≥20%)
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- Off-white (milky or gray), thin, homogeneous discharge
- Refrain from using any intravaginal products during the investigation period
- Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or use a condom during rest of the investigation period to Visit 3.
Who cannot join
- Hypersensitivity or allergy to the investigational devices or to chemically related products
- Current use of an intrauterine device.
- Current pregnancy or intention to become pregnant within 1 month after treatment
- Antibiotic treatment within 2 weeks before treatment
- Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
- Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
Show all 9Show fewer
- Existing or suspected vaginal or cervical cancer or ulcer
- Unprotected vaginal sex within 24 hours prior to Visit 1
- Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation (e.g. hysterectomised or inability to report daily using smartphone/computer [eDiary]).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Sweden8 sites
Ladulaas Kliniska Studier
Borås
Hoftekliniken,
Helsingborg
Qvinnolivet Praktikertjänst AB
Kungsbacka
Hälsomedicinskt Center Barnmorskemottagning
Lomma
2Heal Medical
Stockholm
Kvinnokliniken, Danderyds Sjukhus
Stockholm
Ondrasek Läkarmottagning
Sundsvall
Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus
Umeå
About this study
Official title: A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms, and the Vaginal Environment in Patients With Bacterial Vaginosis
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.
- Being tested
- D005 Vaginal Mousse, Placebo
- Keywords
- women's health, bakteriell vaginos
- 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
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| D005 Vaginal Mousse | Experimental | Not described Receives: Device: D005 Vaginal Mousse |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria:
- Off-white (milky or gray), thin, homogeneous discharge.
- The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.
- A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH).
Measured: 1 to 3 days after last dosing
Secondary outcomes (12)
Clinical cure rate
Clinical cure at Visit 3, defined as absence of all of the following 3 Amsel criteria:
- Off-white (milky or gray), thin, homogeneous discharge.
- The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.
- A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.
Measured: 23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2
Measured: 1 to 3 days after last dosing
Modified Hay/Ison <grade III at Visit 3
Measured: 23 to 28 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 2
Measured: 1 to 3 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 3
Measured: 23 to 28 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2
Vaginal malodour, discharge and itch will be graded as the following:
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
Measured: 1 to 3 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3
Vaginal malodour, discharge and itch will be graded as the following:
Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
Measured: 23 to 28 days after last dosing
pH of the vaginal fluid during treatment
Measured: Day 1-7
pH of the vaginal fluid at Visit 2
Measured: 1 to 3 days after last dosing
pH of the vaginal fluid at Visit 3
Measured: 23 to 28 days after last dosing
Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Measured: 1 to 3 days + 23 to 28 days after last dosing
Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Measured: 1 to 3 days + 23 to 28 days after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start12 Feb 2021
- Primary completion4 Oct 2023
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis | Vaginal | MicrobiologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, CPS Research, Scandinavian Development Services AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489290
- Sponsor's protocol ID
- Piva01
- Status last verified
- Oct 2023
- First submitted
- 24 Jul 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms, and the Vaginal Environment in Patients With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT04489290
- Acronym / sponsor ID
- Piva01
- Keywords
- women's health, bakteriell vaginos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, CPS Research, Scandinavian Development Services AB
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 28 Jul 2020 (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 a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D005 Vaginal Mousse | Experimental | Device: D005 Vaginal Mousse |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willingness and ability to provide informed consent
- Female in fertile age
- Age ≥18 years
- Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
- Refrain from using any intravaginal products during the investigation period
Key exclusion criteria (9 listed)
- Hypersensitivity or allergy to the investigational devices or to chemically related products
- Current use of an intrauterine device.
- Current pregnancy or intention to become pregnant within 1 month after treatment
- Antibiotic treatment within 2 weeks before treatment
- Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
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 MousseD005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis. | Device | D005 Vaginal Mousse |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Clinical cure rate
Time frame: 1 to 3 days after last dosing
Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria: 1. Off-white (milky or gray), thin, homogeneous discharge. 2. The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination. 3. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH).
12 secondary outcomes
Clinical cure rate
Time frame: 23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2
Time frame: 1 to 3 days after last dosing
Modified Hay/Ison <grade III at Visit 3
Time frame: 23 to 28 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 2
Time frame: 1 to 3 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 3
Time frame: 23 to 28 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2
Time frame: 1 to 3 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3
Time frame: 23 to 28 days after last dosing
pH of the vaginal fluid during treatment
Time frame: Day 1-7
pH of the vaginal fluid at Visit 2
Time frame: 1 to 3 days after last dosing
pH of the vaginal fluid at Visit 3
Time frame: 23 to 28 days after last dosing
Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Time frame: 1 to 3 days + 23 to 28 days after last dosing
Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Time frame: 1 to 3 days + 23 to 28 days after last dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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.
9 sites in 2 countries: 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 Vaginosis | Vaginal | Microbiology, run by PepTonic Medical AB at 9 sites in 2 countries.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 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 9 sites in Sweden, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Clinical cure rate (time frame: 1 to 3 days after last dosing). 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 26 Oct 2023.