Atrophic Vaginitis
Conditions
Brief summary
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
Interventions
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
Sponsors
Stratpharma AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent * Diagnosed acute or chronic Atrophic Vaginitis * Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT
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 * Currently on HRT (orally or topically) * Currently on corticosteroid treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Vulvar Quality of Life | 3 months | Vulvar Quality of Life Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported symptoms | 3 months | Likert scales to measure: * Pruritus/itchiness * Tender/sore * Swelling * Dryness * Burning of skin * Dyspareunia * Stinging with urination/clothes * Defecating pain/burning |
| Severity of overall condition | 3 months | Clinician-rated severity of atrophic vaginitis |
| Product rating | 3 months | Likert scale for product rating by the patient |
Countries
United States
Outcome results
None listed