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

NCT07346287 | Recruiting Phase 4 FDA Device

• 1 other identifier: SPAMG08
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Vaginal Health Index Score (VHIS)

  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.

  30 - 45 days

• Vulvar Disease Quality of Life Index questionnaire

  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.

  30 - 45 days

• Investigator-reported improvement in vaginal atrophy signs

  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.

  30-45 days

• Recovery Improvement Question

  Descriptive patient-related questions, assessing the improvement post-laser therapy.

  30-45 days

Secondary Outcomes (1)

• Change in complication rate

  30 - 45 days

Study Arms (1)

Safety

EXPERIMENTAL

Device: 7-940

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 gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.

Safety

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (1)

Orange Coast Women's Medical Group

Laguna Hills, California, 92653, United States

RECRUITING

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: August 13, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)