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

NCT ID: NCT05050981

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-02-28

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.

Conditions

Menopause

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hormone Therapy

Women using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms.

Hormone replacement therapy

Intervention Type: DRUG

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

Selective Serotonin Reuptake Inhibitors

Women using selective serotonin reuptake inhibitors for treating climacteric symptoms.

Selective serotonin reuptake inhibitors

Intervention Type: DRUG

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

Control Group

Women not using hormone replacement therapy or selective serotonin reuptake inhibitors

No interventions assigned to this group

Interventions

Hormone replacement therapy

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

Intervention Type: DRUG

Selective serotonin reuptake inhibitors

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Medicina do ABC

OTHER

Sponsor Role: lead

Responsible Party

Luciano de Melo Pompei'

Auxiliary Professor at Gynecology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciano M Pompei

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Locations

Centro de Atenção Integral à Saúde da Mulher

São Bernardo do Campo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

40147320.5.0000.0082

Identifier Type: -

Identifier Source: org_study_id