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

NCT04766957 | Completed

• 1 other identifier: IDRA
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 4

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.

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

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

  4 and 12 weeks

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

  4 and 12 weeks

• To evaluate the effect of Idracare® gel using vaginal pH

  4 and 12 weeks

• To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells.

  4 and 12 weeks

• To evaluate the effect of Idracare® gel using vaginal microbiota.

  4 and 12 weeks

Study Arms (1)

Idracare

EXPERIMENTAL

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

Device: Idracare

Interventions

Idracare DEVICE

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

Idracare

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Women with vulvovaginal atrophy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (4)

Clínica Sagrada Familia

Barcelona, 08022, Spain

Location

HM Gabinete Velázquez

Madrid, 28001, Spain

Location

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 28009, Spain

Location

HU Miguel Servet

Zaragoza, 50009, Spain

Location

Study Officials

• Josep Combalia, MD

  Procare health Iberia

  STUDY DIRECTOR

• Fernando Losa, Doctor

  Clínica Sagrada Familia

  PRINCIPAL INVESTIGATOR

• Santiago Palacios, Doctor

  Instituto Palacios de Salud y Medicina de la Mujer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open study, only one arm

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 23, 2021
• Study Start: October 26, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 2, 2022
• Last Updated: January 27, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

ES (4)