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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Sponsor: Stratpharma AG
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2023-10-30
Completion Date
2028-12
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
7-0940
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)
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States
Velvet Clinical Research
Burbank, California, United States
Orange Coast Women's Medical Group
Laguna Hills, California, United States
WR-PRI, LLC (Los Alamitos)
Los Alamitos, California, United States
WR-PRI, LLC (Newport Beach)
Newport Beach, California, United States
WR-Women's Health Care Research, LLC
San Diego, California, United States
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-Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
WR-Charleston Clinical Trials, LLC
Charleston, South Carolina, United States
Southern Urogynecology
West Columbia, South Carolina, United States
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, United States
WR-Global Medical Research, LLC
Dallas, Texas, United States