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Device
Gel Dressing 7-0940 for Vulvovaginal Atrophy (VALOR Trial)
N/A
Recruiting
Research Sponsored by Stratpharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
Continuous vulvovaginal symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
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.
Who is the study for?
This trial is for adult women with vaginal atrophy, lichen sclerosus, lichen simplex chronicus or lichen planus who have ongoing symptoms. Participants need to have access to a smart device and email. Women using recent hormonal therapies, systemic corticosteroids, or those allergic to the gel's ingredients cannot join.Check my eligibility
What is being tested?
The VALOR trial is testing a new gel dressing on female adults with certain vulvovaginal conditions. The study aims to evaluate both the immediate and long-term safety and effectiveness of this novel treatment option.See study design
What are the potential side effects?
Potential side effects are not specified but may include skin reactions like irritation or allergy due to the ingredients in the gel dressing being tested.
VALOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific skin or vaginal condition.
Select...
I have ongoing symptoms affecting my vulva or vagina.
VALOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
Secondary outcome measures
Adverse Reactions
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
+3 moreVALOR Trial Design
1Treatment groups
Experimental Treatment
Group I: FeasibilityExperimental Treatment1 Intervention
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Who is running the clinical trial?
Stratpharma AGLead Sponsor
10 Previous Clinical Trials
980 Total Patients Enrolled
2 Trials studying Atrophic Vaginitis
64 Patients Enrolled for Atrophic Vaginitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Feasibility
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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