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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05050981
Enrollment
74
Registered
2021-09-21
Start date
2021-03-01
Completion date
2022-02-28
Last updated
2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

menopause, hormone replacement therapy, selective serotonin reuptake inhibitors, sexual function, quality of life, cognition

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.

Interventions

DRUGHormone replacement therapy

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

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

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026