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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: Hormone replacement therapy; Drug: Selective serotonin reuptake inhibitors

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Bernardo do Campo, SP, Brazil, 09760-280
      • Centro de Atenção Integral à Saúde da Mulher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women aged between 45 and 65 years who are literate treated with hormone replacement therapy or selective serotonin reuptake inhibitors for relieve of cllimacteric symptoms, or not yet under any of both treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hormone Therapy; Women using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms.	Drug: Hormone replacement therapy; 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.	Drug: Selective serotonin reuptake inhibitors; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (ACTUAL): September 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; menopause; cognition; sexual function; hormone replacement therapy; selective serotonin reuptake inhibitors
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Hormones; Serotonin; Serotonin Uptake Inhibitors
• Other Study ID Numbers: 40147320.5.0000.0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small study to know regional data