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

NCT ID: NCT07346287

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2026-04-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Safety

Group Type: EXPERIMENTAL

7-940

Intervention Type: 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.

Interventions

7-940

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stratpharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orange Coast Women's Medical Group

Laguna Hills, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Marc Winter, MD

Role: primary

949-829-5533

Other Identifiers

SPAMG08

Identifier Type: -

Identifier Source: org_study_id