VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Launched by STRATPHARMA AG · Jul 11, 2023

Keywords

ClinConnect Summary

The VALOR trial is studying a new gel dressing designed to treat certain skin conditions in the vaginal area, such as vaginal atrophy, lichen sclerosus, lichen simplex chronicus, and lichen planus. These conditions can cause discomfort and ongoing symptoms for women, particularly during and after menopause. This trial aims to see how safe and effective this gel is both in the short term and over a longer period.

To participate, women aged 65 to 74 who have been diagnosed with one of these conditions and are experiencing continuous symptoms may be eligible. Participants will need access to a smartphone, tablet, or computer to help with the study. Throughout the trial, participants can expect to apply the gel dressing as directed and share their experiences. It's important to note that women who are currently receiving specific hormone treatments or have certain allergies may not qualify for the trial. This study hopes to provide valuable insights into managing these conditions and improving quality of life for women affected by them.

Gender

FEMALE

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