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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.
Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active product | Other |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal gel | Device | The placebo gel is a non-buffered gel. The active device is an acidic gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2). | Clinical cure is defined based on the following Amsel criteria:
| 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure rate (based on Nugent score <4) at Visit 2 | The secondary objective of the study is to confirm the secondary efficacy of the product. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Zeneli, MD | Contact | 0031614706949 | diana.pasho@karopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Peters | Recruiting | Hamburg | Germany |
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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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| ID | Term |
|---|---|
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |
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double blinded, randomized placebo controlled.
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |