Trials / Recruiting
RecruitingNCT07346287
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy (ASSIST-VLA)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Stratpharma AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2025-08-13
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2026-01-16
- Last updated
- 2026-01-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07346287. Inclusion in this directory is not an endorsement.