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| Name | Class |
|---|---|
| Evidilya S.r.l. | INDUSTRY |
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The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A: medical device Celegyn® | Experimental | Medical device Celegyn® presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use. Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
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| GROUP B: matching placebo | Placebo Comparator | Investigational Product (IP) placebo presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use. Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celegyn® | Device | Medical device Celegyn® presents itself as a cream. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Vaginal Health Index (VHI) | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of vulvar signs of VVA assessed by means of vulvoscopy | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Bertolino, PhD | Contact | +390249530065 | antonio.bertolino@evidilya.com | |
| Cesare Mutti | Contact | +390249530065 | cesare.mutti@evidilya.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Not yet recruiting | Brescia | 25123 | Italy |
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randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study
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| Matching placebo |
| Device |
IP placebo presents itself as a cream. |
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comparison between groups, mean change from Day 0 to Day 21 |
| from Day 0 to Day 21 |
| Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6) | comparison between groups, at Day 21 | at Day 21 |
| Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to 21 |
| Assessment of global severity score for symptoms of VVA | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Assessment of pain through the short form of McGill Pain questionnaire | comparison between groups, mean change from Day 0 to Day 21 | from Day 0 to Day 21 |
| Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10) | comparison between groups, at Day 21 | at Day 21 |
| Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4) | comparison between groups, at Day 21 | at Day 21 |
| Assessment of rescue product use (starting date and number of times the rescue product was used) | comparison among groups, at Day 21 | at Day 21 |
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
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