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

NCT05050981 | Completed

• 1 other identifier: 40147320.5.0000.0082
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

menopause; hormone replacement therapy; selective serotonin reuptake inhibitors; sexual function; quality of life; cognition

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Hormone Therapy

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

Drug: Hormone replacement therapy

Selective Serotonin Reuptake Inhibitors

Women using selective serotonin reuptake inhibitors for treating climacteric symptoms.

Drug: Selective serotonin reuptake inhibitors

Control Group

Women not using hormone replacement therapy or selective serotonin reuptake inhibitors

Interventions

Hormone replacement therapy DRUG

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

Hormone Therapy

Selective serotonin reuptake inhibitors DRUG

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

Selective Serotonin Reuptake Inhibitors

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Centro de Atenção Integral à Saúde da Mulher

São Bernardo do Campo, São Paulo, 09760-280, Brazil

Location

MeSH Terms

Interventions

Hormone Replacement Therapy; Selective Serotonin Reuptake Inhibitors

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Luciano M Pompei

  Faculdade de Medicina do ABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Auxiliary Professor at Gynecology Department

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 21, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)