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

Primary Purpose

Vulvovaginal Atrophy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Idracare
Sponsored by
Procare Health Iberia S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Sagrada Familia
  • HM Gabinete Velázquez
  • Instituto Palacios de Salud y Medicina de la Mujer
  • HU Miguel Servet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idracare

Arm Description

The treatment will be applied 2 times a week, preferably at night before going to bed.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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)

Full Information

First Posted
February 13, 2021
Last Updated
January 26, 2023
Sponsor
Procare Health Iberia S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04766957
Brief Title
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Acronym
IDRA
Official Title
Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procare Health Iberia S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open study, only one arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idracare
Arm Type
Experimental
Arm Description
The treatment will be applied 2 times a week, preferably at night before going to bed.
Intervention Type
Device
Intervention Name(s)
Idracare
Intervention Description
Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.
Primary Outcome Measure Information:
Title
Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA)
Description
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
Title
Safety of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) measuring the incidence, nature and severity of adverse events (AE).
Description
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 Outcome Measure Information:
Title
To evaluate the effect of Idracare® gel using Bachmann Vaginal Health Index (BVHI).
Description
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
Title
To evaluate the effect of Idracare® gel using vulvar health index (VHI).
Description
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
Title
To evaluate the effect of Idracare® gel using vaginal pH
Description
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.
Time Frame
4 and 12 weeks
Title
To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells.
Description
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.
Time Frame
4 and 12 weeks
Title
To evaluate the effect of Idracare® gel using vaginal microbiota.
Description
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.
Time Frame
4 and 12 weeks
Title
The degree of satisfaction with the use of Idracare®
Description
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).
Time Frame
4 and 12 weeks
Title
The tolerability of the treatment using a 5-point Likert-type scale
Description
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)
Time Frame
4 and 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with vulvovaginal atrophy
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Combalia, MD
Organizational Affiliation
Procare health Iberia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fernando Losa, Doctor
Organizational Affiliation
Clínica Sagrada Familia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Santiago Palacios, Doctor
Organizational Affiliation
Instituto Palacios de Salud y Medicina de la Mujer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Sagrada Familia
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
HM Gabinete Velázquez
City
Madrid
ZIP/Postal Code
28001
Country
Spain
Facility Name
Instituto Palacios de Salud y Medicina de la Mujer
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
HU Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study documentation will be shared after study completion

Learn more about this trial

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

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