Clinical Efficacy and Gynecological Acceptance of the Product

Not Applicable

• Conditions: Intervention in women from 40 to 80 years of age who present postmenopausal atrophic vaginitis; Intervention in women from 40 to 80 years of age presenting unspecified urinary incontinence; N95.2

• Registration Number: RBR-8dzth2
• Lead Sponsor: Medcin Instituto da Pele Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.