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The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients apply 7-0940 at least 2 times daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Film forming silicone gel (7-0940) | Device | Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Vulvar Quality of Life | Vulvar Quality of Life Index | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported symptoms | Likert scales to measure:
| 3 months |
| Severity of overall condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange Coast Women's Medical Group | Laguna Hills | California | 92653 | United States |
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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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|
Clinician-rated severity of atrophic vaginitis
| 3 months |
| Product rating | Likert scale for product rating by the patient | 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |