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| ID | Type | Description | Link |
|---|---|---|---|
| Hyalofemme | Registry Identifier | Hyalofemme |
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| Name | Class |
|---|---|
| Fidia Farmaceutici s.p.a. | INDUSTRY |
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This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid vaginal gel (Hyalofemme) | Experimental | The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g |
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| Estriol cream (Ovestin) | Active Comparator | The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyalofemme | Device | The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of improvement of vaginal dryness symptoms | percentage of improvement of vaginal dryness symptoms at the baseline and after treatment | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of improvement of itching, dyspareunia and burning sensation | percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Estriol cream (Ovestin) | Device | The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g |
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