Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

October 24, 2023 updated by: Pharmiva AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Borås, Sweden
        • Ladulaas Kliniska Studier
      • Helsingborg, Sweden
        • Hoftekliniken,
      • Kungsbacka, Sweden
        • Qvinnolivet Praktikertjänst AB
      • Lomma, Sweden
        • Hälsomedicinskt Center Barnmorskemottagning
      • Stockholm, Sweden
        • 2Heal Medical
      • Stockholm, Sweden
        • Kvinnokliniken, Danderyds Sjukhus
      • Sundsvall, Sweden
        • Ondrasek Läkarmottagning
      • Umeå, Sweden
        • Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus
  • United Kingdom
    • Scottland
      • Glasgow, Scottland, United Kingdom, G20 0XA
        • CPS Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Willingness and ability to provide informed consent
  2. Female in fertile age
  3. Age ≥18 years

  4. Bacterial vaginosis, as defined by the following criteria (Amsel criteria):

    1. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
    2. Presence of clue cells (≥20%)
    3. Off-white (milky or gray), thin, homogeneous discharge
  5. Refrain from using any intravaginal products during the investigation period
  6. Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or use a condom during rest of the investigation period to Visit 3.

Exclusion Criteria:

  1. Hypersensitivity or allergy to the investigational devices or to chemically related products
  2. Current use of an intrauterine device.
  3. Current pregnancy or intention to become pregnant within 1 month after treatment
  4. Antibiotic treatment within 2 weeks before treatment
  5. Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
  6. Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
  7. Existing or suspected vaginal or cervical cancer or ulcer
  8. Unprotected vaginal sex within 24 hours prior to Visit 1
  9. 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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: D005 Vaginal Mousse
Device: D005 Vaginal Mousse
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 to 3 days after last dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical cure rate
Time Frame: 23 to 28 days after last dosing

Clinical cure at Visit 3, 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 KOH.
23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2
Time Frame: 1 to 3 days after last dosing
1 to 3 days after last dosing
Modified Hay/Ison <grade III at Visit 3
Time Frame: 23 to 28 days after last dosing
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
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
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

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
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

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
23 to 28 days after last dosing
pH of the vaginal fluid during treatment
Time Frame: Day 1-7
Day 1-7
pH of the vaginal fluid at Visit 2
Time Frame: 1 to 3 days after last dosing
1 to 3 days after last dosing
pH of the vaginal fluid at Visit 3
Time Frame: 23 to 28 days after last dosing
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
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
1 to 3 days + 23 to 28 days after last dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmiva AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CPS Research
Scandinavian Development Services AB
Key2Compliance AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Piva01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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