Intervention in women from 40 to 80 years of age who present postmenopausal atrophic vaginitis
Conditions
Interventions
66 participants, female, aged 40 to 80 years, healthy with complaints of urinary incontinence and or vaginal atrophy.
Group 1 participants with urinary incontinence and Group 2 participants with vagi
Drug
Other
C13.351.500.894.906.316
Sponsors
Medcin Instituto da Pele Ltda
Medcin Instituto da Pele Ltda
Eligibility
Sex/Gender
Female
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 66 female participants; aged 40 to 80 years; healthy with complaints of urinary incontinence and vaginal atrophy who wish to participate in the study.
Exclusion criteria
Exclusion criteria: Gestation or risk of gestation; use of anti-inflammatory drugs; immunosuppressants in the last 30 days or during the study; active cutaneous conditions; history of product irritation at the site of evaluation; endocrine pathologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the research product in the improvement of the hydration of the intimate area and the discomfort caused by urinary incontinence and genital atrophy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the perception of the volunteer regarding the sexual sensitivity, lubrication, sensation of comfort and improvement in the urinary incontinence with the use of the investigational product;;To evaluate the perception of the volunteer regarding the sexual sensitivity, lubrication, sensation of comfort as to the vaginal atrophy with the use of the investigational product;;Assess usage safety by verifying occurrences of product-related adverse events. | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed