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

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

Article specifications

This multicenter, randomized, controlled, open-label, parallel-group, clinical trial was published in 2013 in The Journal of Sexual Medicine (IF 2014:3.151) by Chinese and Italian gynecologists. In this study the efficacy and safety of hyaluronic acid vaginal gel were compared with estriol Cream in post menopause women with vaginal atrophy and took place at four centers in China. 144 subjects (were all 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) were divided in 2 groups: 72 to the test group treated with hyaluronic acid vaginal gel (Hyalofemme) and 72 to the control group treated with estriol cream (Ovestin). Treatment in both groups was applied by means of a device once every 3 days for a total of 10 applications over 30 days.

Results

This study demonstrated that hyaluronic acid vaginal gel can relieve symptoms of vaginal dryness. Therefore, the gel may be considered not only a valid alternative treatment for patients unwilling or unable to consider estrogen therapy but also for general use in treating vaginal dryness symptoms whatever the cause.

The hyaluronic acid vaginal gel has no hormone-like effect; thus, it had no influence on the endometrium or the hormone-endocrine system and had a high safety profile.