Actively Recruiting
Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy (ASSIST-VLA)
Led by Stratpharma AG · Updated on 2026-01-16
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a gel called 7-940 for women with vaginal atrophy who have recently undergone vaginal laser therapy. This phase 4 study focuses on how well the gel works as an additional treatment to improve symptoms related to vaginal atrophy, such as dryness, tenderness, and discomfort. The study uses both patient and investigator reports to assess clinical outcomes and monitors safety and symptom changes throughout the trial. Participants will apply the 7-940 gel daily following their vaginal laser therapy sessions. The gel is a non-hormonal, non-steroidal product designed to support vaginal mucosal health and speed recovery by promoting a moist healing environment. It is intended as an alternative to estrogen and corticosteroid treatments, aiming to relieve symptoms like itchiness, burning, and painful intercourse, and to improve tissue conditions such as thinning and scarring. During the study, participants will undergo assessments including the Vaginal Health Index Score, the Vulvar Disease Quality of Life questionnaire, and investigator evaluations of vaginal atrophy signs around 30 to 45 days after treatment. Researchers will monitor symptom progression and any complications during this period. Participants will be involved in regular evaluations and provide feedback on their recovery, with the overall study lasting through these follow-up assessments.
CONDITIONS
Brief Title
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed vaginal atrophy
- Access to smartphone and tablet, laptop or computer
- Access to a valid email address
- Previously completed laser therapy session schedule
You will not qualify if you...
- 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 or steroidal therapy started less than 30 days before baseline ( = not yet on a stable regimen)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 to 45 days
Participants use the 7-940 gel, a non-hormonal and non-steroidal device that supports vulvovaginal mucosal conditions and speeds up recovery following vaginal rejuvenation laser therapy.
Trial Site Locations
Total: 1 location
1
Orange Coast Women's Medical Group
Laguna Hills, California, United States, 92653
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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