Atrophic Vaginitis study: 7-0940
Official title VALOR: Vaginal Atrophy & Long-term Observation of Recovery
ClinicalTrials.gov ID: NCT05953090
What this study is testing
- What it's testing
- The study aims to learn whether the gel dressing is safe and works over short and long periods.
- Who it's for
- Adult women who have vaginal atrophy, lichen sclerosus, lichen simplex chronicus, or lichen planus of the vulva.
- What's involved
- Participants will use the gel dressing as instructed and attend study visits for safety checks and effectiveness tests.
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 is enrolling
- Birmingham, Alabama, United States
- Burbank, California, United States
- Newport Beach, California, United States
- Fayetteville, North Carolina, United States
- West Columbia, South Carolina, 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Burbank, California, United States; Newport Beach, California, United States; Fayetteville, North Carolina, United States; West Columbia, South Carolina, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.