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To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Experimental | 220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months) |
|
| Placebo | Placebo Comparator | two tablets/day for 10 days, and subsequently one tablet/day for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Atrophic vaginal changes | Morphometric analysis of biopsies. | Change from baseline epithelium at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Itching | Scale: absent, mild, moderate, severe. | Change from baseline Itching at 3 months |
| Assessment of Burning | Scale: absent, mild, moderate, severe. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina. | Messina | Italy |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Change from baseline Burning at 3 months |
| Assessment of Dyspareunia | Scale: absent, mild, moderate, severe. | Change from baseline Dyspareunia at 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |