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New treatment option for Atrophic Vaginitis
Official title VALOR: Vaginal Atrophy & Long-term Observation of Recovery
ClinicalTrials.gov ID: NCT05953090
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Burbank, California, United States
- Laguna Hills, California, United States
- Los Alamitos, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Lake City, Florida, United States
- Sandy Springs, Georgia, United States
- Las Vegas, Nevada, United States
- Fayetteville, North Carolina, United States
- Charleston, South Carolina, United States
- West Columbia, South Carolina, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Burbank, California, United States; Laguna Hills, California, United States; Los Alamitos, California, United States; Newport Beach, California, United States; San Diego, California, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.