Multicentre Clinical Trial. Project EXIMe

NCT03558451 | Completed

• 1 other identifier: CCI 24/16
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Menopause

Keywords

Primary health care

Outcome Measures

Primary Outcomes (1)

• Main-Quality of life in menopause

  Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)

  Change from baseline Quality of life at six months

Secondary Outcomes (4)

• Sexual function

  Change from baseline at six months

• vaginal pH

  Change from baseline at six months

• Oxford scale

  Change from baseline at six months

• Urine sediment

  Change from baseline at six months

Study Arms (2)

EXIMe intervention

EXPERIMENTAL

In addition to the usual assistance, women will receive 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: Complex intervention in sexual health; Other: Usual care

Usual care

ACTIVE COMPARATOR

Usual care according to available protocols applicable to the women and the health service standardized portfolio

Other: Usual care

Interventions

Complex intervention in sexual health OTHER

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.

Also known as: Usual care

EXIMe intervention

Usual care OTHER

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

Also known as: Women will receive the usual assistance

EXIMe intervention; Usual care

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged between 45-65 years with Genitourinary Syndrome of Menopause

You may not qualify if:

• women who present pathologies that lead to an alteration of sexual desire
• women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy
• women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause
• women who could not read or write, and not understand the spanish language.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid: collaborator

Study Sites (1)

Gerencia de Atención Primaria, Madrid

Madrid, 28035, Spain

Location

MeSH Terms

Interventions

Sexual Health

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Lucia Martinez-Villarejo, Midwife

  Gerencia de Atención Primaria, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only primary care midwives know and apply the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: June 15, 2018
• Study Start: July 10, 2017
• Primary Completion: October 15, 2018
• Study Completion: March 15, 2019
• Last Updated: August 11, 2022

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)