Skip to main content
OpenTrials
Completed

NCT Number: NCT05050981

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro de Atenção Integral à Saúde da Mulher

São Bernardo do Campo, São Paulo, 09760-280, Brazil

About this study

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.

Who can participate

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

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.

Treatment and study plan

hormone replacement therapy

Drug

Hormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin.

Selective serotonin reuptake inhibitors

Drug

Selective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc.

Primary outcomes

  1. Score at Female Sexual Function Index scale (DSDI)

    Time frame: Day 1

    Association between treatments and FSFI global score

  2. Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)

    Time frame: Day 1

    Association between treatments and WHOQOL-Bref score

  3. Score at Mini-Mental State Examination scale

    Time frame: Day 1

    Association between treatments and Mini-Mental State Examination score

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Sep 10, 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.

Published trials that share one or more normalized conditions with this study.