Vulvovaginal AtrophyIDRANCT04766957
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
A study testing Idracare in people with Vulvovaginal Atrophy, run by Procare Health Iberia S.L. at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Idracare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 4 sitesSpain
- Study dates
- 26 Oct 2020to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Clínica Sagrada Familia
Barcelona, 08022
HM Gabinete Velázquez
Madrid, 28001
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 28009
HU Miguel Servet
Zaragoza, 50009
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Idracare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdracareDevice
Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.
| Study group | Role | What they receive |
|---|---|---|
| Idracare | Experimental | The treatment will be applied 2 times a week, preferably at night before going to bed. Receives: Device: Idracare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start26 Oct 2020
- Primary completion31 Dec 2021
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open study, only one arm
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Combalia, MD, Study director, Procare health IberiaFernando Losa, Doctor, Principal investigator, Clínica Sagrada FamiliaSantiago Palacios, Doctor, Principal investigator, Instituto Palacios de Salud y Medicina de la Mujer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766957
- Sponsor's protocol ID
- IDRA
- Acronym
- IDRA
- Status last verified
- Dec 2022
- First submitted
- 13 Feb 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study documentation will be shared after study completion
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT04766957
- Acronym / sponsor ID
- IDRA / IDRA
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open study, only one arm
| Arm | Type | Receives |
|---|---|---|
| Idracare | Experimental | Device: IdracareThe treatment will be applied 2 times a week, preferably at night before going to bed. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdracareTreatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed. | Device | Idracare |
Primary outcome
Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA)
Time frame: Through study completion, an average of 12 weeks
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).
Time frame: Through study completion, an average of 12 weeks
To evaluate the safety of Idracare® gel, the incidence, nature and severity of adverse events (AE) will be studied.
7 secondary outcomes
To evaluate the effect of Idracare® gel using Bachmann Vaginal Health Index (BVHI).
Time frame: 4 and 12 weeks
To evaluate the effect of Idracare® gel using vulvar health index (VHI).
Time frame: 4 and 12 weeks
To evaluate the effect of Idracare® gel using vaginal pH
Time frame: 4 and 12 weeks
To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells.
Time frame: 4 and 12 weeks
To evaluate the effect of Idracare® gel using vaginal microbiota.
Time frame: 4 and 12 weeks
The degree of satisfaction with the use of Idracare®
Time frame: 4 and 12 weeks
The tolerability of the treatment using a 5-point Likert-type scale
Time frame: 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: Yes. The study documentation will be shared after study completion
Related trials for Vulvovaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Combalia, MD study director
Procare health Iberia
Fernando Losa, Doctor principal investigator
Clínica Sagrada Familia
Santiago Palacios, Doctor principal investigator
Instituto Palacios de Salud y Medicina de la Mujer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Idracare in people with Vulvovaginal Atrophy, run by Procare Health Iberia S.L. at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) (time frame: Through study completion, an average of 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.