MenopauseNCT05050981
Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake Inhibitor on Cognition, Sexual Function and Quality of Life
An observational study of Menopause, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Hormone replacement therapy and Selective serotonin reuptake inhibitors
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atenção Integral à Saúde da Mulher
São Bernardo do Campo, São Paulo, 09760-280
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause
- Being tested
- Hormone replacement therapy, Selective serotonin reuptake inhibitors
- Keywords
- menopause, hormone replacement therapy, selective serotonin reuptake inhibitors, sexual function, quality of life, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone replacement therapyDrug
Hormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin.
Selective serotonin reuptake inhibitorsDrug
Selective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc.
| Study group | Role | What they receive |
|---|---|---|
| Hormone Therapy | Women using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms. Receives: Drug: Hormone replacement therapy | |
| Selective Serotonin Reuptake Inhibitors | Women using selective serotonin reuptake inhibitors for treating climacteric symptoms. Receives: Drug: Selective serotonin reuptake inhibitors | |
| Control Group | Women not using hormone replacement therapy or selective serotonin reuptake inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at Female Sexual Function Index scale (DSDI)
Association between treatments and FSFI global score
Measured: Day 1
Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)
Association between treatments and WHOQOL-Bref score
Measured: Day 1
Score at Mini-Mental State Examination scale
Association between treatments and Mini-Mental State Examination score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano de Melo Pompei', Faculdade de Medicina do ABC
- Investigators
- Luciano M Pompei, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050981
- Sponsor's protocol ID
- 40147320.5.0000.0082
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a small study to know regional data
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05050981
- Acronym / sponsor ID
- 40147320.5.0000.0082
- Conditions
- Menopause
- Keywords
- menopause, hormone replacement therapy, selective serotonin reuptake inhibitors, sexual function, quality of life, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hormone Therapy | – | Drug: Hormone replacement therapyWomen using hormone replacement therapy (estrogen only or oestrogen and progestin) for treating climacteric symptoms. |
| Selective Serotonin Reuptake Inhibitors | – | Drug: Selective serotonin reuptake inhibitorsWomen using selective serotonin reuptake inhibitors for treating climacteric symptoms. |
| Control Group | – | –Women not using hormone replacement therapy or selective serotonin reuptake inhibitors |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone replacement therapyHormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin. | Drug | Hormone Therapy |
| Selective serotonin reuptake inhibitorsSelective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc. | Drug | Selective Serotonin Reuptake Inhibitors |
Primary outcome
Score at Female Sexual Function Index scale (DSDI)
Time frame: Day 1
Association between treatments and FSFI global score
Score at World Health Organization quality of life assessment - bref scale (WHOQOL-Bref)
Time frame: Day 1
Association between treatments and WHOQOL-Bref score
Score at Mini-Mental State Examination scale
Time frame: Day 1
Association between treatments and Mini-Mental State Examination score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No. This is a small study to know regional data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano M Pompei principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at Female Sexual Function Index scale (DSDI) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.