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Completed

NCT Number: NCT03558451

Multicentre Clinical Trial. Project EXIMe

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.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia de Atención Primaria, Madrid

Madrid, 28035, Spain

About this study

Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. 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. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.

Experimental group: 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. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Usual care

Usual Care

Other

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

Other names: Women will receive the usual assistance

Primary outcomes

  1. Main-Quality of life in menopause

    Time frame: Change from baseline Quality of life at six months

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

Secondary outcomes

  1. Sexual function

    Time frame: Change from baseline at six months

    Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care"

  2. vaginal pH

    Time frame: Change from baseline at six months

    vaginal pH

  3. Oxford scale

    Time frame: Change from baseline at six months

    Oxford scale: pelvic floor muscle response

  4. Urine sediment

    Time frame: Change from baseline at six months

    Urine sediment

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

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

Registry information

Official study title

Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe

Acronym: EXIMe

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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