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The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.
The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| female subjects, 18-59 y, healthy | Experimental | 74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health care product (intimate gel) | Other | heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Hydration | Evaluate the perceived hydration through a subjective questionnaire | 28 ± 2 days |
| Hydration (device) | Evaluate the hydration, through a hydration measurements by chronometry. | 28 ± 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Natural defenses preservation (pH) | pH measurements | 28 ± 2 days |
| Natural defenses preservation (microbiota) | bacterioscopic collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmética Ltda | Campinas | São Paulo | 13084-791 | Brazil |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Clinical trial, single-arm
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| 28 ± 2 days |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |