Multicentre Clinical Trial. Project EXIMe

Menopause Clinical Trial

— EXIMe  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558451
• Other study ID #: CCI 24/16
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: August 2019
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 15, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

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.
• Usual care
According to available protocols applicable to the patient and the health service standardized portfolio

Locations

Country	Name	City	State
Spain	Gerencia de Atención Primaria, Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sexual function	Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care"	Change from baseline at six months
Secondary	vaginal pH	vaginal pH	Change from baseline at six months
Secondary	Oxford scale	Oxford scale: pelvic floor muscle response	Change from baseline at six months
Secondary	Urine sediment	Urine sediment	Change from baseline at six months