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

NCT04766957 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-01-27

No results posted yet for this study

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

Interventions

DEVICE

Idracare

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

Sponsors & Collaborators

  • Procare Health Iberia S.L.

    lead INDUSTRY

Principal Investigators

  • Josep Combalia, MD · Procare health Iberia

  • Fernando Losa, Doctor · Clínica Sagrada Familia

  • Santiago Palacios, Doctor · Instituto Palacios de Salud y Medicina de la Mujer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2021-12-31
Completion
2022-12-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766957 on ClinicalTrials.gov