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

Stratpharma

Status and phase: Enrolling; Phase 4

Conditions: Atrophic Vaginitis; Vaginal Atrophy; Genitourinary Syndrome of Menopause (GSM)

Treatments: Device: 7-940

Study type: Interventional

Funder types: Industry

Identifiers

NCT07346287

SPAMG08

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Safety

Experimental group

Treatment:

Device: 7-940