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

Procare Health Iberia S.L.134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Vulvovaginal Atrophy

Interventions

IdracareDEVICE

Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

Clínica Sagrada Familia

Barcelona, Spain

HM Gabinete Velázquez

Madrid, Spain

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain

HU Miguel Servet

Zaragoza, Spain

Outcomes

Primary Outcomes

Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA)

To evaluate the efficacy of the Idracare® gel as a treatment for the symptoms of VVA, the percentage of women who present changes in dryness and / or dyspareunia has been established as the main variable.

Time frame: Through study completion, an average of 12 weeks

Safety of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) measuring the incidence, nature and severity of adverse events (AE).

To evaluate the safety of Idracare® gel, the incidence, nature and severity of adverse events (AE) will be studied.

Time frame: Through study completion, an average of 12 weeks

Secondary Outcomes

To evaluate the effect of Idracare® gel using Bachmann Vaginal Health Index (BVHI).

Effect of Idracare® gel will be evaluated on vaginal health status using Bachmann Vaginal Health Index (BVHI). It consists of 5 domains that evaluate different parameters (elasticity, fluids, pH, epithelial integrity and moisture) scoring each one of them independently, considering the maximum score as the best vaginal health status.

Time frame: 4 and 12 weeks

To evaluate the effect of Idracare® gel using vulvar health index (VHI).

Effect of Idracare® gel will be evaluated on vaginal health status using vulvar health index (VHI). It consists of 8 domains that evaluate different parameters: physiological state of the labia majora, labia minora, clitoris, urethra, coloration, elasticity / introitus, discomfort / pain and other findings) scoring each of them independently, considering the maximum score as the worse in vulvar health.

Time frame: 4 and 12 weeks

To evaluate the effect of Idracare® gel using vaginal pH

Effect of Idracare® gel will be evaluated on vaginal health status using vaginal pH changes. A lower pH compared to basal is considered an improvement on vaginal health status.

Data from ClinicalTrials.gov

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