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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormone Therapy | Women using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms. |
| |
| Selective Serotonin Reuptake Inhibitors | Women using selective serotonin reuptake inhibitors for treating climacteric symptoms. |
| |
| Control Group | Women not using hormone replacement therapy or selective serotonin reuptake inhibitors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormone replacement therapy | Drug | Hormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Luciano M Pompei | Faculdade de Medicina do ABC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atenção Integral à Saúde da Mulher | São Bernardo do Campo | São Paulo | 09760-280 | Brazil |
This is a small study to know regional data
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| Selective serotonin reuptake inhibitors | Drug | Selective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc. |
|
| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
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