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Gel Dressing 7-0940 for Vulvovaginal Atrophy (VALOR Trial)
VALOR Trial Summary
This trial will test a new gel dressing to treat vulvovaginal skin conditions in adult women. It will assess safety and effectiveness in the short and long term.
VALOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVALOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VALOR Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with a specific skin or vaginal condition.I have a valid email address.I started hormone therapy less than 30 days ago.I haven't used topical HRT or corticosteroids for my condition in the last 30 days.I am unable to understand and agree to the study's details on my own.I cannot use skin-applied medical devices by myself.I have used corticosteroids in the last 30 days or am currently using them.I have ongoing symptoms affecting my vulva or vagina.I am currently using topical hormone replacement therapy or corticosteroids for my condition.
- Group 1: Feasibility
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is access to this experiment available to participants at the present time?
"According to the information available on clinicaltrials.gov, this particular trial is no longer accepting candidates. It was first posted October 1st 2023 and its latest update was July 11th 2023. Nevertheless, there are 214 other trials that remain open for participation at present time."
What are the primary aims of this experiment?
"This clinical trial has two primary objectives: to measure the shift in Vulvar Disease Quality of Life Index (VQLI) score from baseline after 12 months, and patient-rated symptom severity on a 10-point Likert scale. Secondary outcomes include investigator-assessed visual pathology as well as any adverse reactions documented over 3 month, 6 month, 9 month and 12 month intervals."
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