Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.

Inclusion Criteria:

• Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L, or had been surgically postmenopausal for more than 6 months)
• Women between 45 and 75 years of age.
• Vaginal pH ≥5
• Vulvovaginal atrophy with VHI < 15
• At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
• Women with active sex lives
• Patients who give written informed consent to participate in the trial

Exclusion Criteria:

• Enrollment in other clinical trials within the previous 1 month.
• Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
• Patients in previous treatment with either oral or topical hormonal products within 1 month.
• Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
• Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
• Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
• Women with no active sex lives
• Women who do not give informed consent;
• Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient