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

NCT ID: NCT04766957

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-12-02

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.

Conditions

Vulvovaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Idracare

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

Group Type: EXPERIMENTAL

Idracare

Intervention Type: DEVICE

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

Interventions

Idracare

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Procare Health Iberia S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep Combalia, MD

Role: STUDY_DIRECTOR

Procare health Iberia

Fernando Losa, Doctor

Role: PRINCIPAL_INVESTIGATOR

Clínica Sagrada Familia

Santiago Palacios, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Palacios de Salud y Medicina de la Mujer

Locations

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

Countries

Spain

Other Identifiers

IDRA

Identifier Type: -

Identifier Source: org_study_id