NCT04247022

Evaluation of Gynecological Acceptability of a Health Care Product

Evaluation of Cutaneous Acceptability and Genital Mucosa Acceptability of a Health Care Product (Intimate Gel), and Interference of Microbiota and pH Around the Vaginal Introit, With Instrumental Evaluation of the Mucosa Hydratation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Herbarium Laboratorio Botanico Ltda · Industry
• Sex: Female
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events. The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.

Detailed description

74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.

Conditions

• Atrophic Vaginitis
• Vaginal Diseases

Interventions

Type	Name	Description
OTHER	Health care product (intimate gel)	heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2020-01-29
• Last updated: 2021-08-02

Locations

1 site across 1 country: Brazil