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Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness
Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.
Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).
Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: vaginal gel new formulation | Active Comparator | Application once a day at evening during the first study week of the vaginal gel new formulation (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal gel on the market (hyaluronic acid). |
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| Arm II: vaginal gel on the market | Active Comparator | Application once a day at evening during the first study week of the vaginal gel on the market (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal new formulation (hyluronic acid). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid | Drug | Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Humidity determination | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability assessment | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adele Sparavigna, Physician | Derming SRL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermIng S.r.l | Monza | MB | 20900 | Italy |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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