Laser plus daily 7-0940® for improving vaginal atrophy symptoms
Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy (ASSIST-VLA)
This study will try adding a daily topical 7-0940® treatment after a vaginal laser session to see if it reduces symptoms in people with vaginal atrophy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stratpharma AG Industry-sponsored |
| Locations | 1 site (Laguna Hills, California) |
| Trial ID | NCT07346287 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study enrolls people with diagnosed vaginal atrophy who have completed a laser therapy schedule and will apply a daily topical product (7-0940®) following a laser session. Clinical outcomes will be measured using validated investigator- and patient-reported instruments, with regular safety checks and monitoring of symptom progression. Participants must have basic digital access (smartphone and email) for study communications and remote data capture. The trial is conducted at a single site in Laguna Hills, California, under sponsorship of Stratpharma AG.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with vaginal atrophy who have completed their laser therapy schedule, can self-apply a topical product, and have access to a smartphone or computer and an email address.
Not a fit: Patients with known allergy to the product ingredients, those unable to self-apply the topical product, or those who started systemic hormonal or steroid therapy less than 30 days before baseline are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the adjunctive daily 7-0940® could prolong or enhance symptom relief after vaginal laser therapy and improve comfort for patients with genitourinary syndrome of menopause.
How similar studies have performed: Vaginal laser therapy has shown mixed results in prior studies and adjunct topical regimens are less well studied, so combining laser with a novel topical product is relatively novel with limited direct precedents.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Laguna Hills, California
- Orange Coast Women's Medical Group — Laguna Hills, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.