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| Name | Class |
|---|---|
| Key2Compliance | INDUSTRY |
| CPS Research | UNKNOWN |
| Scandinavian Development Services AB | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D005 Vaginal Mousse | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D005 Vaginal Mousse | Device | D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria:
| 1 to 3 days after last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Clinical cure at Visit 3, defined as absence of all of the following 3 Amsel criteria:
| 23 to 28 days after last dosing |
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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):
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ladulaas Kliniska Studier | Borås | Sweden | ||||
| Hoftekliniken, |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| Placebo | Other | Placebo |
|
| 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 |
| Helsingborg |
| Sweden |
| Qvinnolivet Praktikertjänst AB | Kungsbacka | Sweden |
| Hälsomedicinskt Center Barnmorskemottagning | Lomma | Sweden |
| 2Heal Medical | Stockholm | Sweden |
| Kvinnokliniken, Danderyds Sjukhus | Stockholm | Sweden |
| Ondrasek Läkarmottagning | Sundsvall | Sweden |
| Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus | Umeå | Sweden |
| CPS Research | Glasgow | Scottland | G20 0XA | United Kingdom |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |