NCT04245293

Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device AINARA® Vaginal Gel Versus A Hyaluronic Acid-Based Gel In Late Menopausal Transition Women Affected By Vaginal Dryness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness

Detailed description

This is an open, comparative, multicenter study that evaluates the performance and safety of the medical device Ainara®. In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue Scale.

Conditions

• Vaginal Disease

Interventions

Type	Name	Description
DEVICE	Ainara	Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).
DEVICE	HyaloGin	Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger. The gel quantity is enough for one subject (3g application every three days over the course of the study).

Timeline

• Start date: 2019-04-11
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2020-01-28
• Last updated: 2020-01-28

Locations

1 site across 1 country: Romania