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The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment.
The primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age between 18 and 75 years, female |
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| Measure | Description | Time Frame |
|---|---|---|
| efficacy endpoint: VAS score for symptoms | The primary efficacy endpoint is based on the VAS score for symptoms (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment reported below. | "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy: evaluation of pH | evaluation of pH with instrument for pH | "From enrollment to the end of treatment at 12 days (after menstrual cycle) |
| efficacy: VAS evaluation | The change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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Female: form 18 - 75 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ambrogio Frigerio, Medical doctor (gynecology) | Contact | +39 02 994303352 | afrigerio@asst-rhodense.it | |
| Andrea Borgatta | Contact | +393472644870 | andreaborgatta@nextrasearch.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95 | Garbagnate Milanese | Michigan | 20024 | Italy |
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| From enrollment to the end of treatment at 12 days (after menstrual cycle) |
| safety endpoint | The safety and tolerability of the treatments will be evaluated by investigating local and expected adverse events, as a consequence of the application of the product and any other adverse events occurring during the study. | From enrollment to the end of treatment at 12 days (after menstrual cycle) |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009181 | Mycoses |
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