Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA). To assess the Safety and efficacy of INNEA AQUA
Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA). To assess the Safety and efficacy of INNEA AQUA
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
the comparator is the standard of care selected by the centre
Obstretics and Gynaecology Filantropia Clinical Hospital
Bucharest, Romania, Romania
Nicolae Malaxa Clinical Hospital
Bucharest, Romania, Romania
AMCA Medical Clinic
Bucharest, Romania, Romania
safety: Incidence of AE and SAE
To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: change in pruritus
Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: Change in soreness
Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: change in dyspareunia
Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in irritation
Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of pH
Vaginal Ph Normalization
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
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efficacy: change in vaginal moisture
Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in VHX
Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of vaginal aging
Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
safety (AE/SAE)
Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the patient
Participant satisfaction in using the Device (PGI-I) Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the investigator
Investigator satisfaction in using the Device (VAS) Day 120
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of quality of life
Change in baseline score in QoL score when compared to Day 30, 51 and 120.
Time frame: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection