MenopauseNCT05072756
Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive Habits
An observational study of Menopause and Opinions, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
To evaluate Brazilian gynecologists, through structured online questionnaires, with questions directed to their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Menopause, Opinions, Hormone Replacement Therapy
- What is being tested?
- Applying a questionnaire
- How many people
- 1,339 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Apr 2021to 4 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Active Brazilian licensed gynecologist doctors who see patients
Who may be able to join
- Brazilian licensed gynecologist doctors
Who cannot join
- Retired doctors
- Health professionals other than medicine doctor
- Medical specialties other than Gynecology
- Medical employees of the pharmaceutical industry
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: Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive
To evaluate Brazilian gynecologists, through structured online questionnaires, with questions directed to their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online.
Read the detailed description
There are few Brazilian population studies on the opinion of Brazilian gynecologists about the hormonal therapy of menopause in climacteric women, their prescriptive habits and their views on the availability of treatments offered, demanding better evaluation and justifying efforts to analyze the perception of professionals in this area in our country.
Methods: To assess gynecologists across the country, through structured online questionnaires, with questions aimed at knowing their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online. Doctors will be invited to participate by e-mail messages and by social media.
- Conditions
- Menopause, Opinions, Hormone Replacement Therapy
- Being tested
- Applying a questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying a questionnaireOther
The participants have to answer a questionnaire addressing their opinion on menopausal hormone replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Gynecologists | Brazilian gynecologists who agreed to participate and answered the questionnaire Receives: Other: Applying a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription preference
Answer to the questionnaire addressing gynecologists' prescription habit for menopausal women
Measured: At Day 1
Secondary outcomes (2)
Knowledge of window of opportunity for hormone replacement therapy
This is to see which proportion of gynecologists know the principle of window of opportunity for menopausal hormone replacement therapy
Measured: At Day 1
Knowledge of indications and contraindications of hormone replacement therapy
This is to see which proportion of gynecologists know the indications and contraindicationsv of menopausal hormone replacement therapy
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start28 Apr 2021
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,339 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
- NCT05072756
- Sponsor's protocol ID
- 40147120.8.0000.0082
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not an interventional study, so, the researches understand that there is no reason to share individual participant data.
Publications
Taylor HS, Kagan R, Altomare CJ, Cort S, Bushmakin AG, Abraham L. Knowledge of clinical trials regarding hormone therapy and likelihood of prescribing hormone therapy. Menopause. 2017 Jan;24(1):27-34. doi: 10.1097/GME.0000000000000711.
PubMed 27575548Buhling KJ, von Studnitz FS, Jantke A, Eulenburg C, Mueck AO. Use of hormone therapy by female gynecologists and female partners of male gynecologists in Germany 8 years after the Women's Health Initiative study: results of a survey. Menopause. 2012 Oct;19(10):1088-91. doi: 10.1097/gme.0b013e318250bfda.
PubMed 22692331Yeganeh L, Boyle J, Teede H, Vincent A. Knowledge and attitudes of health professionals regarding menopausal hormone therapies. Climacteric. 2017 Aug;20(4):348-355. doi: 10.1080/13697137.2017.1304906. Epub 2017 Apr 5.
PubMed 28379046
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive
- ClinicalTrials.gov ID
- NCT05072756
- Acronym / sponsor ID
- 40147120.8.0000.0082
- Conditions
- Menopause, Opinions, Hormone Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,339 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 11 Oct 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.
To evaluate Brazilian gynecologists, through structured online questionnaires, with questions directed to their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online.
Detailed description
There are few Brazilian population studies on the opinion of Brazilian gynecologists about the hormonal therapy of menopause in climacteric women, their prescriptive habits and their views on the availability of treatments offered, demanding better evaluation and justifying efforts to analyze the perception of professionals in this area in our country.
Methods: To assess gynecologists across the country, through structured online questionnaires, with questions aimed at knowing their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online. Doctors will be invited to participate by e-mail messages and by social media.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologists | – | Other: Applying a questionnaireBrazilian gynecologists who agreed to participate and answered the questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Active Brazilian licensed gynecologist doctors who see patients
Key inclusion criteria (1 listed)
- Brazilian licensed gynecologist doctors
Key exclusion criteria (4 listed)
- Retired doctors
- Health professionals other than medicine doctor
- Medical specialties other than Gynecology
- Medical employees of the pharmaceutical industry
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 |
|---|---|---|
| Applying a questionnaireThe participants have to answer a questionnaire addressing their opinion on menopausal hormone replacement therapy | Other | Gynecologists |
Primary outcome
Prescription preference
Time frame: At Day 1
Answer to the questionnaire addressing gynecologists' prescription habit for menopausal women
2 secondary outcomes
Knowledge of window of opportunity for hormone replacement therapy
Time frame: At Day 1
Knowledge of indications and contraindications of hormone replacement therapy
Time frame: At Day 1
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 11 Oct 2021.
- Background: PubMed 27575548Taylor HS, Kagan R, Altomare CJ, Cort S, Bushmakin AG, Abraham L. Knowledge of clinical trials regarding hormone therapy and likelihood of prescribing hormone therapy. Menopause. 2017 Jan;24(1):27-34. doi: 10.1097/GME.0000000000000711.
- Background: PubMed 22692331Buhling KJ, von Studnitz FS, Jantke A, Eulenburg C, Mueck AO. Use of hormone therapy by female gynecologists and female partners of male gynecologists in Germany 8 years after the Women's Health Initiative study: results of a survey. Menopause. 2012 Oct;19(10):1088-91. doi: 10.1097/gme.0b013e318250bfda.
- Background: PubMed 28379046Yeganeh L, Boyle J, Teede H, Vincent A. Knowledge and attitudes of health professionals regarding menopausal hormone therapies. Climacteric. 2017 Aug;20(4):348-355. doi: 10.1080/13697137.2017.1304906. Epub 2017 Apr 5.
- Individual participant dataSharing planned: No. This is not an interventional study, so, the researches understand that there is no reason to share individual participant 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 and Opinions, 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 1 inclusion and 4 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 11 Oct 2021. 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?
Prescription preference (time frame: At Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072756, which also lists 3 linked publications.
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 11 Oct 2021.