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

Part of paid clinical trials in Laguna Hills, California.

Sponsor
Stratpharma AG
Study ID
NCT07346287
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Safety

Primary Outcome Measure

Vaginal Health Index Score (VHIS) [ Time Frame: 30 - 45 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Orange Coast Women's Medical GroupLaguna HillsCalifornia92653
Marc Winter, MD
949-829-5533
Marc Winter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Laguna Hills, CA

By research site
Orange Coast Women's Medical Group· Laguna Hills, CA

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