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Multicentre Clinical Trial. Project EXIMe

NCT03558451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-08-11

No results posted yet for this study

Summary

Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.

Conditions

Interventions

OTHER

Complex intervention in sexual health

EXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.

OTHER

Usual care

According to available protocols applicable to the patient and the health service standardized portfolio

Sponsors & Collaborators

  • Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid

    collaborator UNKNOWN

  • Gerencia de Atención Primaria, Madrid

    lead OTHER_GOV

Principal Investigators

  • Lucia Martinez-Villarejo, Midwife · Gerencia de Atención Primaria, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2018-10-15
Completion
2019-03-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT03558451 on ClinicalTrials.gov