NCT04245358

Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Open Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Ainara® Vaginal Gel, In Post-Menopausal Women Affected By Vaginal Dryness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.

Detailed description

Detailed Description: This is an open, non-comparative, multicenter study that evaluates the performance and safety of the medical device Ainara. In this study the investigators use polycarbophilic vaginal moisturizing gel (Ainara) for symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.

Conditions

• Vaginal Disease

Interventions

Type	Name	Description
DEVICE	Ainara	1g of gel per administration

Timeline

• Start date: 2019-09-20
• Primary completion: 2019-12-09
• Completion: 2019-12-09
• First posted: 2020-01-28
• Last updated: 2021-05-10

Locations

1 site across 1 country: Romania