VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Stratpharma AG
2,000 participants
Oct 30, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.
Locations(14)
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NCT05953090