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临床试验/NCT05050981
NCT05050981已完成不适用

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

Faculdade de Medicina do ABC1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Score at Female Sexual Function Index scale (DSDI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Hormone Therapy

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

干预措施: Hormone replacement therapy (Drug)

Selective Serotonin Reuptake Inhibitors

Women using selective serotonin reuptake inhibitors for treating climacteric symptoms.

干预措施: Selective serotonin reuptake inhibitors (Drug)

结局指标

主要结局

Score at Female Sexual Function Index scale (DSDI)

时间窗: Day 1

Association between treatments and FSFI global score

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

时间窗: Day 1

Association between treatments and WHOQOL-Bref score

Score at Mini-Mental State Examination scale

时间窗: Day 1

Association between treatments and Mini-Mental State Examination score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciano de Melo Pompei'

Auxiliary Professor at Gynecology Department

Faculdade de Medicina do ABC

研究点 (1)

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