26/10/2018

Safety and efficacy of a hyaluronic acid derivative in the treatment of vulvovaginal atrophy

Fidia farmaceutici announces the results of a prospective clinical investigation aimed at assessing the effectiveness and the safety of Hydeal-D vaginal pessaries, composed of an ester of hyaluronic acid, in the treatment of vulvovaginal atrophy in post-menopause women.

Vulvovaginal atrophy in post-menopause women

The results of the prospective clinical investigation involving 40 post-menopause women, presented by Prof. Rossella Nappi at the EUGA 2018 Congress, have demonstrated that 3-month Hydeal-D vaginal pessaries treatment led to a progressive, significant improvement of objective and subjective vulvovaginal atrophy (VVA) signs and symptoms, both at 1 and 3 months.

Significant improvement of signs and symptoms

Vaginal Health Index (VHI), study primary outcome, increased considerably during 3-month Hydeal-D vaginal pessaries treatment in overall index in 80% of patients (p<0.0001). Significant improvements were also observed in patient’s perception of vaginal symptoms associated with VVA, such as dryness, irritation/itching, soreness, dysuria, dyspareunia (p<0.0001), as well as in vaginal pH, which returned to physiological values in over 50% of patients (p<0.0001), after 3 months of treatment.

Reduced personal distress

Even the personal distress assessed by FSDS-R was significantly reduced in 70% of women, who reported an improvement in sexual function after 3-month Hydeal-D vaginal pessaries treatment (p<0.0001), as well as a reduction of related sexual dysfunction (p<0.0001).

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Fidia operates in numerous therapeutic areas, providing specific, innovative treatments for commonly occurring pathologies with major socio-economic impact, namely:

- joint healthcare
- ophthalmology
- wound care
- dermatology
- neurology
- dermo-aesthetics