Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Open study with only one arm. The study has a total duration per patient of 3 months: initial visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12 weeks of treatment.

Inclusion Criteria:

• Women who attend medical centers, either for a visit related to vulvovaginal atrophy (VVA) or for any other reason for consultation, with symptoms of VVA (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the Likert scale).
• Women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period.
• Women are able to understand and sign the informed consent after the nature of the study has been fully explained to them.

Exclusion Criteria:

• Pregnant or immediate postpartum patients (up to 40 days).
• Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment.
• Use of any other experimental drug or device during the 30 days prior to screening.
• Use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit.
• Use of contraceptives for vaginal application.
• Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.)
• Undiagnosed abnormal genital bleeding or presence of vaginal lesion.
• Active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study.
• Impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.