VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Recruiting now · Not applicable
Conditions studied: Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva, Lichen Planus of Vulva, Lichen Simplex of Vulva (Disorder)
In brief
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.
Key facts
- Study ID
- NCT05953090
- Run by
- Stratpharma AG
- People needed
- 2000
- Starts
- 2023-10-30
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Cahaba Dermatology & Skin Health Center — Birmingham, Alabama, United States (enrolling)
- Velvet Clinical Research — Burbank, California, United States (enrolling)
- WR-PRI, LLC (Newport Beach) — Newport Beach, California, United States (enrolling)
- WR-Carolina Institute for Clinical Research — Fayetteville, North Carolina, United States (enrolling)
- Southern Urogynecology — West Columbia, South Carolina, United States (enrolling)
- WR-Global Medical Research, LLC — Dallas, Texas, United States (enrolling)
- WR-Multi-Specialty Research Associates — Lake City, Florida, United States
- WR-Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
- WR-Clinical Research Center of Nevada, LLC — Las Vegas, Nevada, United States
- WR-Medical Research Center of Memphis, LLC — Memphis, Tennessee, United States
- Orange Coast Women's Medical Group — Laguna Hills, California, United States
- WR-PRI, LLC (Los Alamitos) — Los Alamitos, California, United States
- WR-Charleston Clinical Trials, LLC — Charleston, South Carolina, United States
- WR-Women's Health Care Research, LLC — San Diego, California, United States
Full record on ClinicalTrials.gov
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