NCT01557179

Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness

Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.

Conditions

• The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness

Interventions

Type	Name	Description
DEVICE	Hyalofemme	The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g
DEVICE	Estriol cream (Ovestin)	The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-11-01
• Completion: 2010-05-01
• First posted: 2012-03-19
• Last updated: 2012-03-19