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Treatment for vaginal atrophy and related conditions using a novel gel dressing

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Not applicable Interventional Stratpharma AG · NCT05953090

This study is testing a new gel dressing to see if it can help adult women with vaginal atrophy and other skin conditions feel better.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2000 (estimated)
Ages18 Years and up
SexFemale
SponsorStratpharma AG Industry-sponsored
Locations14 sites (Birmingham, Alabama and 13 other locations)
Trial IDNCT05953090 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on treating vulvovaginal skin conditions such as vaginal atrophy, lichen sclerosus, and lichen planus in adult women using a new gel dressing. The study aims to evaluate both the short- and long-term safety and efficacy of this treatment. Participants will be monitored for their symptoms and overall recovery throughout the trial period. The study involves a series of assessments to determine the effectiveness of the gel in alleviating symptoms associated with these conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are women diagnosed with atrophic vaginitis, lichen sclerosus, lichen simplex chronicus, or lichen planus who experience continuous vulvovaginal symptoms.

Not a fit: Patients who are currently undergoing systemic hormonal therapy or have allergies to the treatment ingredients may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for women suffering from vaginal atrophy and related conditions.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating vulvovaginal conditions with topical therapies.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 13 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrophic VaginitisVaginal AtrophyGenitourinary Syndrome of MenopauseLichen Sclerosus of VulvaLichen Planus of VulvaLichen Simplex of Vulva
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.