Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID07346287

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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