Clinical trial NCT05050981: Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake Inhibitor on Cognition, Sexual Function and Quality of Life
Official title: Comparison of Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: menopause
hormone replacement therapy
selective serotonin reuptake inhibitors
sexual function
quality of life
cognition
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 74
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Score at Female Sexual Function Index scale (DSDI)
timeFrame: Day 1
measure: Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)
timeFrame: Day 1
measure: Score at Mini-Mental State Examination scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: São Bernardo do Campo
country: Brazil
facility: Centro de Atenção Integral à Saúde da Mulher
state: SP
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Luciano M Pompei
role: PRINCIPAL_INVESTIGATOR
References: