Treatment for vaginal atrophy and related conditions using a novel gel dressing
Official title: VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Run by Stratpharma AG · NCT05953090 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | Stratpharma AG Industry-sponsored |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Status | Recruiting |
| Started | October 30, 2023 |
| Main results expected | June 2028 |
| Study ends | December 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT05953090 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are currently undergoing systemic hormonal therapy or have allergies to the treatment ingredients may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, similar studies have shown promise in treating vulvovaginal conditions with topical therapies.
Who can join: the full rules
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 it's running
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Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States Recruiting -
Velvet Clinical Research
Burbank, California, United States Recruiting -
WR-PRI, LLC (Newport Beach)
Newport Beach, California, United States Recruiting -
WR-Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States Recruiting -
Southern Urogynecology
West Columbia, South Carolina, United States Recruiting -
WR-Global Medical Research, LLC
Dallas, Texas, United States Recruiting
Show 8 more locations
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Orange Coast Women's Medical Group
Laguna Hills, California, United States Active not recruiting -
WR-PRI, LLC (Los Alamitos)
Los Alamitos, California, United States Not yet recruiting -
WR-Women's Health Care Research, LLC
San Diego, California, United States Not yet recruiting -
WR-Multi-Specialty Research Associates
Lake City, Florida, United States Not yet recruiting -
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States Not yet recruiting -
WR-Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States Not yet recruiting -
WR-Charleston Clinical Trials, LLC
Charleston, South Carolina, United States Not yet recruiting -
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, United States Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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F-GYN injection for vaginal dryness and vaginal/vestibular atrophy
This study tests whether a one-time F-GYN injection can relieve vaginal dryness and related symptoms in adult women with atrophic vaginitis/vestibulovaginal atrophy compared with standard non-hormonal care.
-
Burden of vaginal and urinary menopause symptoms in breast cancer survivors
This study will see how common and how severe genitourinary menopause symptoms are in breast cancer survivors receiving single-mode cancer treatment compared with controls.
-
Pixel CO2 (FemiLift) laser treatment for vulvo-vaginal atrophy
This trial tests whether the Pixel CO2 (FemiLift) laser can relieve symptoms and restore healthier vaginal tissue in postmenopausal women with vulvo-vaginal atrophy.
-
Nonhormonal vulvovaginal gel to relieve menopausal vulvovaginal symptoms
This will test a hormone-free vulvovaginal gel in postmenopausal women with genitourinary syndrome of menopause to see if it reduces vaginal atrophy symptoms and improves daily quality of life.
-
Combining topical hyaluronic acid with high-concentration oxygen therapy for menopausal symptoms
This study is testing if a treatment that combines a special gel and high-concentration oxygen can help postmenopausal women, including those who had breast cancer, feel better by reducing vaginal dryness and other symptoms.
-
Er:YAG laser plus vaginal estriol for menopausal genitourinary symptoms
This trial will test whether adding Er:YAG laser treatment to low‑dose vaginal estriol helps postmenopausal women with genitourinary syndrome of menopause.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.