Bacterial Vaginosis | Vaginal | Microbiology
Conditions
Keywords
women's health, bakteriell vaginos
Brief 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. The study population will consist of approximately 83 female subjects.
Interventions
DEVICED005 Vaginal Mousse
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
OTHERPlacebo
Placebo
Sponsors
Key2Compliance
CPS Research
Scandinavian Development Services AB
PepTonic Medical AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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 \[eDiary\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Clinical cure rate | 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. |
| 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 | — |
| Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3 | 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 |
Countries
Sweden, United Kingdom
Outcome results
None listed