Atrophic Vaginitis, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy
Conditions
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.
Interventions
DEVICE7-940
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.
Sponsors
Stratpharma AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Health Index Score (VHIS) | 30 - 45 days | 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. |
| Vulvar Disease Quality of Life Index questionnaire | 30 - 45 days | 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. |
| Investigator-reported improvement in vaginal atrophy signs | 30-45 days | 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. |
| Recovery Improvement Question | 30-45 days | Descriptive patient-related questions, assessing the improvement post-laser therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in complication rate | 30 - 45 days | Any adverse reactions or complications, are rated by the investigator during each assessment baseline and after 30 - 45 days. |
Countries
United States
Outcome results
None listed