NCT05953090 VALOR: Vaginal Atrophy & Long-term Observation of Recovery
| NCT ID | NCT05953090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stratpharma AG |
| Condition | Atrophic Vaginitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2028-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.
Eligibility Criteria
Inclusion Criteria: * Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus * Continuous vulvovaginal symptoms * Access to smartphone and tablet, laptop or computer * Access to a valid email address Exclusion Criteria: * Unable to provide informed consent * Patient unable to apply topical device * Allergy or intolerance to ingredients or excipients of the formulation of studied products * Systemic hormonal therapy started less than 30 days before baseline * Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline * Ongoing topical HRT or corticosteroid treatment for the indication under investigation * Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline