ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy

What this trial studies

Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment. Clinical outcomes will be assessed using validated investigator- and patient-reported measures, with safety and symptom progression monitored throughout the study.

Conditions in scope

• Vaginal Atrophy
• Atrophic Vaginitis
• Genitourinary Syndrome of Menopause (GSM)

Interventions

• 7-940 (Device) — A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The…

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• Diagnosed vaginal atrophy
• Access to smartphone and tablet, laptop or computer
• Access to a valid email address
• Previously completed laser therapy session schedule

Exclusion criteria

• 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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2025-08-13
• Primary completion: 2026-04
• Last update posted: 2026-01-16
• First posted: 2026-01-16

Sponsor & contact

Lead sponsor: Stratpharma AG (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vaginal Health Index Score (VHIS) (30 - 45 days)
  Objective clinical assessment for assessment of the device safety as adjunctive treatment after laser therapy forr women with vaginal atrophy. The objective validation of clinical signs (elasticity, fluid volume, pH, epithelial integrity, moisture) using a commonly used scale.
• Vulvar Disease Quality of Life Index questionnaire (30 - 45 days)
  The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). \[min:0; max:45\]. A higher score thereby correlates to a worse outcome. The secondary endpoint is the change from baseline VQLI score at 30 - 45 days.
• Investigator-reported improvement in vaginal atrophy signs (30-45 days)
  Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 30 - 45 days, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
• Recovery Improvement Question (30-45 days)
  Descriptive patient-related questions, assessing the improvement post-laser therapy.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.