Open, Non-controlled Clinical Studies to Assess the Efficacy and Safety of a Medical Device in Form of Gel Topically and Intravaginally Used in Postmenopausal Women with Genital Atrophy

Abstract

Menopause is often associated with vaginal atrophy and related symptoms, such as vaginal dryness, burning, itching, and dyspareunia, decrease in libido and in general a decrease in the quality of life. The common treatment up to the 1990's has been the oral hormone replacement therapy (HRT), but this treatment has been consequently re-considered due to its adverse effects. Topical estrogenic products have been subsequently developed to minimize the systemic adverse effects of the oral HRT, but they are still considered at risk in case of prolonged use. As an alternative, two clinical trials were performed to investigate the effects of a medical device in the form of a gel, containing hyaluronic acid, liposomes, phytoestrogens from Humulus lupulus extract, and Vitamin E, with the aim of testing its safety and efficacy in post-menopausal women with urogenital atrophy. The first pilot study confirmed in 10 women the good safety profile, both locally and systemically, of the device applied on the external genitals at the dose of 1-2 g/day for 30 days. The second study was carried out, according to a multicenter, open, non-controlled design, in 100 post-menopausal women assigned to the vaginal application of 2.5 g of gel/day for 1 week followed by two applications/week for 11 weeks. The primary end-point was the evaluation of vaginal dryness assessed by a Visual Analogue Scale both by the investigator and the subject. Secondary endpoints were the evaluation of all other symptoms and signs associated with atrophic vaginitis (itching, burning, dyspareunia, vaginal inflammation/oedema and rash assessed by a 4-point scale and presence of vaginal abrasions and disepithelialisation), and the recording of adverse events during the study. At the end of the treatment, an overall judgment on the efficacy and safety of the device was made by the investigator and a judgment on the acceptability of the treatment was made by the subjects. The results showed a marked effect of the tested product on the vaginal dryness and on all other symptoms and signs with statistically significant reductions since the first week of treatment. No treatment-related adverse events were complained by the subjects and the treatment course showed a high level of acceptability by the subjects. This device could be considered an effective and safe alternative treatment of genital atrophy in post-menopausal women, especially when HRT is not recommended.