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

Completed

• Conditions: Menopause
• Interventions: Drug: Selective serotonin reuptake inhibitors; Drug: Hormone replacement therapy

• Registration Number: NCT05050981
• Lead Sponsor: Faculdade de Medicina do ABC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-21
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Selective Serotonin Reuptake Inhibitors	Selective serotonin reuptake inhibitors	Women using selective serotonin reuptake inhibitors for treating climacteric symptoms.
Hormone Therapy	Hormone replacement therapy	Women using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms.

Primary Outcome Measures

Name	Time	Method
Score at Female Sexual Function Index scale (DSDI)	Day 1	Association between treatments and FSFI global score
Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)	Day 1	Association between treatments and WHOQOL-Bref score
Score at Mini-Mental State Examination scale	Day 1	Association between treatments and Mini-Mental State Examination score

Trial Locations

Locations (1)

Centro de Atenção Integral à Saúde da Mulher; 🇧🇷 São Bernardo do Campo, SP, Brazil