Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake Inhibitor on Cognition, Sexual Function and Quality of Life

Menopause Clinical Trial

Official title:

Comparison of Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050981
• Other study ID #: 40147320.5.0000.0082
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2022
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cross-sectional study with postmenopausal women using hormone therapy or serotonin reuptake inhibitor to relieve climacteric symptoms or without any treatment. Participants will answer three questionnaires: FSFI (the Female Sexual Function Index), MENQOL (Menopause-specific Quality of Life) and MEEM (Mini-Mental State Examination). The results will be compared according to treatment group.

Description:

Climacteric is a period marked by the reduction of estrogen levels, which leads to the occurrence of various symptoms that can affect a woman's physical, mental, sexual health and quality of life. The use of hormonal therapy (HT), with replacement of estrogen or estrogen and progestin, is indicated to alleviate these symptoms, aiming to improve the woman's quality of life. In addition, it is possible to use other forms of treatment to alleviate these symptoms, including selective serotonin reuptake inhibitors (SSRI), which play a major role in vasomotor symptoms. SSRIs have been used with moderate success in women who have contraindications to the use of HT or do not wish to use it. Objective: This study aims to analyze and compare the effects of HT and SSRIs in the treatment of climacteric symptoms in relation to cognitive and sexual function and quality of life in climacteric women. Methodology: This is a cross-sectional study to be carried out with menopausal women treated at the Centro de Atenção Integral à Saúde da Mulher (CAISM) in the city of São Bernardo do Campo/SP/Brazil. Participants who sign the Informed Consent Form will answer 3 questionnaires: FSFI (Female Sexual Function Index), WHOQOL-Bref (World Health Organization Quality of Life Instrument Bref) and MEEM (Mini-Mental State Examination). The results will be compared according to treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women aged between 45 and 65 years who are literate;
• Patients with at least 6 months of follow-up at the institution and who consented to participate in the research.

Exclusion Criteria:

• Women with psychiatric illness;
• Being on medication with action on the Central Nervous System due to psychiatric indication;
• Cognitive impairment that makes it impossible to understand the issues;
• Illiteracy;
• Absence of at least one sexual activity in the last 4 weeks.

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Hormone replacement therapy
Hormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin.
• Selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc.

Locations

Country	Name	City	State
Brazil	Centro de Atenção Integral à Saúde da Mulher	São Bernardo do Campo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score at Female Sexual Function Index scale (DSDI)	Association between treatments and FSFI global score	Day 1
Primary	Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)	Association between treatments and WHOQOL-Bref score	Day 1
Primary	Score at Mini-Mental State Examination scale	Association between treatments and Mini-Mental State Examination score	Day 1