NCT05050981

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Faculdade de Medicina do ABC · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Menopause

Interventions

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

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-09-21
• Last updated: 2022-09-10

Locations

1 site across 1 country: Brazil