RecruitingPhase 4

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

United States10 participantsStarted 2025-08-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Vaginal Health Index Score (VHIS)

Timeframe: 30 - 45 days

Vulvar Disease Quality of Life Index questionnaire

Timeframe: 30 - 45 days

Investigator-reported improvement in vaginal atrophy signs

Timeframe: 30-45 days

Recovery Improvement Question

Timeframe: 30-45 days

Trial details

NCT IDNCT07346287

SponsorStratpharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Vaginal Atrophy trials