Effectiveness and safety of HA vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women

Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial

Article specifications

This open, non-controlled clinical trial was published in 2008 in European Review for Medical and Pharmacological Sciences (IF2016: 1.778) by Italian gynecologists. In this study the efficacy and safety of hyaluronic acid with vitamin A and E in 150 postmenopausal Women (aged between 44 to 64) were evaluated. The prescription was 1 vaginal suppository per day, for the first 14 days and then a vaginal suppository, day in and day out, for other 14 days. Within the period of the study (4 weeks), four visits were performed: at baseline, after 7 days from the beginning of the treatment (visit 1), after 14 days (visit 2) and at the end of the treatment (day 28) (visit 3). The primary endpoint was the evaluation of vaginal dryness assessed by a Visual Analogue Scale (VAS) both by the investigator and the patient.

Results

The result of the study showed that this hyaluronic acid product can be considered a safe and effective alternative for the treatment of vaginal atrophy symptoms in postmenopausal women, especially when HRT is not recommended. The results confirmed a favorable safety profile of the product even after a longer period of treatment. The effectiveness on vaginal dryness and on correlated symptoms was good right from the first week of treatment. The overall judgement on effectiveness and safety was optimal for the main part of the patients. The compliance was favorable in almost the whole group of women treated.