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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid vaginal gel (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: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of improvement of vaginal dryness symptoms	percentage of improvement of vaginal dryness symptoms at the baseline and after treatment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of improvement of itching, dyspareunia and burning sensation	percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment	30 days

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Fidia Farmaceutici s.p.a.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: LEES_Hyalofemme_1; Hyalofemme (Registry Identifier: Hyalofemme)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No