Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

Intervention / Treatment
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* Device: D005 Vaginal Mousse
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%) 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. Exclusion Criteria: 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 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]).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D005 Vaginal Mousse<br> | Device: D005 Vaginal Mousse<br>* D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 to 3 days after last dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 23 to 28 days after last dosing | 
| Modified Hay/Ison <grade III at Visit 2 |  | 1 to 3 days after last dosing | 
| Modified Hay/Ison <grade III at Visit 3 |  | 23 to 28 days after last dosing | 
| Clinical cure + Modified Hay/Ison <grade III at Visit 2 |  | 1 to 3 days after last dosing | 
| Clinical cure + Modified Hay/Ison <grade III at Visit 3 |  | 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 | 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 | 23 to 28 days after last dosing | 
| pH of the vaginal fluid during treatment |  | Day 1-7 | 
| pH of the vaginal fluid at Visit 2 |  | 1 to 3 days after last dosing | 
| pH of the vaginal fluid at Visit 3 |  | 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. |  | 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. |  | 1 to 3 days + 23 to 28 days after last dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women's health, bakteriell vaginos