RecruitingNot Applicable

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

United States2,000 participantsStarted 2023-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.

Timeframe: 12 months

Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months

Timeframe: 12 months

Trial details

NCT IDNCT05953090

SponsorStratpharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Atrophic Vaginitis trials