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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vulvovaginal Atrophy

Intervention / Treatment
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* Device: Idracare


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open study, only one arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idracare<br>The treatment will be applied 2 times a week, preferably at night before going to bed. | Device: Idracare<br>* Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 4 and 12 weeks | 
| To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells. | Effect of Idracare® gel will be evaluated on vaginal health status using Maturation Index (MI). MI is the most commonly used index to assess hormonal status. It evaluates the percentage composition of the three large types of cells that make up the vaginal epithelium in the cytological samples obtained: parabasal, intermediate and superficial. It consists of selecting five fields at random (x 10 magnification) and counting 100 epithelial cells in each area, determining the percentage of superficial, intermediate and parabasal cells in each area. The result is expressed as% parabasal cells:% intermediate cells (navicular):% superficial cells. | 4 and 12 weeks | 
| To evaluate the effect of Idracare® gel using vaginal microbiota. | Effect of Idracare® gel will be evaluated on vaginal health status using vaginal Dysbiosis test. It consists of analyzing by means of real time polymerase chain reaction (real time PCR) different microorganisms that are part of the vaginal ecosystem such as Lactobacillus species (L. crispatus, L. jensenii, L. iners, L. gasseri ), Candida species, lactic acid microbiota (Atopobium, Gardnerella), non-lactic acid microbiota and pathogens. | 4 and 12 weeks | 
| The degree of satisfaction with the use of Idracare® | The degree of satisfaction with the use of Idracare® will be evaluated using a 7-point Likert-type scale, from 1 (satisfied) to 7 (not satisfied at all). | 4 and 12 weeks | 
| The tolerability of the treatment using a 5-point Likert-type scale | The tolerability of the treatment will be evaluated using a 5-point Likert-type scale, from 1 (no problem with the treatment) to 5 (I can't stand the treatment) | 4 and 12 weeks |