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

Phase 2

Completed

• Conditions: The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
• Interventions: Device: Hyalofemme; Device: Estriol cream (Ovestin)

• Registration Number: NCT01557179
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-11
• Study Completion: 2010-05
• Status Verified: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-16
• Last Update Submitted: 2012-03-16
• Study First Posted: 2012-03-19
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• under 70 years old,
• had been naturally or surgically postmenopausal for more than 6 months,
• had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen

Exclusion Criteria

• unmarried, pregnant and breast-feeding women,
• patients with vaginal infections such as trichomonas,
• candida and bacterial vaginosis,
• patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
• genital bleeding of unknown origin,
• patients with acute hepatopathy, embolic disorders,
• severe primary disease of the kidney and hematopoietic system
• recent malignant tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid vaginal gel (Hyalofemme)	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
Estriol cream (Ovestin)	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

Primary Outcome Measures

Name	Time	Method
percentage of improvement of vaginal dryness symptoms	30 days	percentage of improvement of vaginal dryness symptoms at the baseline and after treatment

Secondary Outcome Measures

Name	Time	Method
percentage of improvement of itching, dyspareunia and burning sensation	30 days	percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment