VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStratpharma AG

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 7-0940

Treatment groups

2,000 Participants
are divided into 1 treatment group

Sponsors and collaborators