MenopauseTEMPS-MRSNCT06972290
TEMPS-A and Menopause Symptoms
An observational study of Menopause and Personality, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the relationship between temperament traits and menopausal symptoms using the TEMPS-A and MRS scales in women at menopausal transition stages. It is a cross-sectional observational study. Read more about this study
- Who is it for?
- Ages Up to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Personality, Temperament
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 May 2025
- How long will I take part?
- 1 Day
- 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 Up to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women in the menopausal transition stage, classified as STRAW stages -1, +1a, and +1b, attending menopause outpatient clinics.
Who may be able to join
- Women classified as STRAW stages -1, +1a, and +1b (menopausal transition stages)
- Ability to complete questionnaires and provide informed consent
Who cannot join
- History of hormone therapy during the past 6 months
- History of surgical menopause (bilateral oophorectomy)
- Presence of severe physical disorders (e.g., malignancy, severe cardiovascular diseases)
- Presence of severe psychological disorders (e.g., major depressive disorder, psychosis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Training and Reserach Hospital
Istanbul, 34200
About this study
Official title: The Relationship Between Temperament and Menopause Symptoms: A Cross-Sectional Study Using TEMPS-A and MRS Scales
This study investigates the relationship between temperament traits and menopausal symptoms using the TEMPS-A and MRS scales in women at menopausal transition stages. It is a cross-sectional observational study.
Read the detailed description
This observational, cross-sectional study aims to investigate the relationship between temperament traits and menopausal symptoms in women in the menopausal transition stage, specifically classified as STRAW stages -1, +1a, and +1b. Participants are recruited from menopause outpatient clinics.
Data are collected through the administration of the validated Temperament Evaluation of Memphis, Pisa, Paris and San Diego Autoquestionnaire (TEMPS-A) and the Menopause Rating Scale (MRS).
Participants voluntarily complete the questionnaires after providing informed consent. All responses are anonymized and securely stored.
Quality assurance measures include verification of data entry, use of validated scales, and compliance with ethical standards approved by the Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee.
No interventions are applied; the study strictly follows observational registry procedures.
- Conditions
- Menopause, Personality, Temperament
- Keywords
- Menopausal Transition, Personality Traits, Personality Characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
TEMPS-A Depressive Subscale Score at Baseline
Score from the depressive subscale of the TEMPS-A questionnaire, assessing baseline depressive temperament
Measured: Baseline (single time point at enrollment)
TEMPS-A Cyclothymic Subscale Score at Baseline
Score from the cyclothymic subscale of the TEMPS-A questionnaire, assessing mood instability.
Measured: Baseline (single time point at enrollment)
TEMPS-A Hyperthymic Subscale Score at Baseline
Score from the hyperthymic subscale of the TEMPS-A questionnaire, assessing elevated or overly positive mood tendencies.
Measured: Baseline (single time point at enrollment)
TEMPS-A Irritable Subscale Score at Baseline
Score from the irritable subscale of the TEMPS-A questionnaire, assessing baseline tendency toward irritability.
Measured: Baseline (single time point at enrollment)
TEMPS-A Anxious Subscale Score at Baseline
Score from the anxious subscale of the TEMPS-A questionnaire, assessing trait anxiety.
Measured: Baseline (single time point at enrollment)
MRS Somatic Subscale Score at Baseline
Somatic subscore of the MRS, measuring physical symptoms such as hot flashes and sleep problems.
Measured: Baseline (single time point at enrollment)
MRS Psychological Subscale Score at Baseline
Psychological subscore of the MRS, reflecting symptoms such as depressive mood, irritability, and anxiety.
Measured: Baseline (single time point at enrollment)
MRS Urogenital Subscale Score at Baseline
Urogenital subscore of the MRS, assessing symptoms such as vaginal dryness or urinary complaints.
Measured: Baseline (single time point at enrollment)
MRS Total Score at Baseline
Total score from the Menopause Rating Scale (MRS), reflecting overall menopausal symptom severity.
Measured: Baseline (single time point at enrollment)
Secondary outcomes (1)
Correlation Between TEMPS-A Subscale Scores and MRS Total/Subscale Scores
The relationship between affective temperament traits (TEMPS-A: depressive, cyclothymic, hyperthymic, irritable, and anxious) and menopausal symptom severity (MRS total and subscale scores) will be assessed using Pearson or Spearman correlation coefficients. The analysis aims to determine whether specific temperament profiles are associated with increased symptom burden.
Measured: Baseline (single time point at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jan 2024
- Primary completion15 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cemile ilhan, Bagcilar Training and Research Hospital
- Investigators
- Cemile Ilhan, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972290
- Sponsor's protocol ID
- 777/28.09.23
- Acronym
- TEMPS-MRS
- Status last verified
- Nov 2025
- First submitted
- 27 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayirlioglu N, Ilhan C. Affective Temperament Traits as Predictors of Menopausal Symptom Severity in the Late Menopausal Transition and Early Postmenopause. J Obstet Gynaecol Res. 2026 May;52(5):e70317. doi: 10.1111/jog.70317.
PubMed 42091421
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Temperament and Menopause Symptoms: A Cross-Sectional Study Using TEMPS-A and MRS Scales
- ClinicalTrials.gov ID
- NCT06972290
- Acronym / sponsor ID
- TEMPS-MRS / 777/28.09.23
- Conditions
- Menopause, Personality, Temperament
- Keywords
- Menopausal Transition, Personality Traits, Personality Characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 May 2025 (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.
This study investigates the relationship between temperament traits and menopausal symptoms using the TEMPS-A and MRS scales in women at menopausal transition stages. It is a cross-sectional observational study.
Detailed description
This observational, cross-sectional study aims to investigate the relationship between temperament traits and menopausal symptoms in women in the menopausal transition stage, specifically classified as STRAW stages -1, +1a, and +1b. Participants are recruited from menopause outpatient clinics.
Data are collected through the administration of the validated Temperament Evaluation of Memphis, Pisa, Paris and San Diego Autoquestionnaire (TEMPS-A) and the Menopause Rating Scale (MRS).
Participants voluntarily complete the questionnaires after providing informed consent. All responses are anonymized and securely stored.
Quality assurance measures include verification of data entry, use of validated scales, and compliance with ethical standards approved by the Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee.
No interventions are applied; the study strictly follows observational registry procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women in the menopausal transition stage, classified as STRAW stages -1, +1a, and +1b, attending menopause outpatient clinics.
Key inclusion criteria (2 listed)
- Women classified as STRAW stages -1, +1a, and +1b (menopausal transition stages)
- Ability to complete questionnaires and provide informed consent
Key exclusion criteria (4 listed)
- History of hormone therapy during the past 6 months
- History of surgical menopause (bilateral oophorectomy)
- Presence of severe physical disorders (e.g., malignancy, severe cardiovascular diseases)
- Presence of severe psychological disorders (e.g., major depressive disorder, psychosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TEMPS-A Depressive Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Score from the depressive subscale of the TEMPS-A questionnaire, assessing baseline depressive temperament
TEMPS-A Cyclothymic Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Score from the cyclothymic subscale of the TEMPS-A questionnaire, assessing mood instability.
TEMPS-A Hyperthymic Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Score from the hyperthymic subscale of the TEMPS-A questionnaire, assessing elevated or overly positive mood tendencies.
TEMPS-A Irritable Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Score from the irritable subscale of the TEMPS-A questionnaire, assessing baseline tendency toward irritability.
TEMPS-A Anxious Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Score from the anxious subscale of the TEMPS-A questionnaire, assessing trait anxiety.
MRS Somatic Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Somatic subscore of the MRS, measuring physical symptoms such as hot flashes and sleep problems.
MRS Psychological Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Psychological subscore of the MRS, reflecting symptoms such as depressive mood, irritability, and anxiety.
MRS Urogenital Subscale Score at Baseline
Time frame: Baseline (single time point at enrollment)
Urogenital subscore of the MRS, assessing symptoms such as vaginal dryness or urinary complaints.
MRS Total Score at Baseline
Time frame: Baseline (single time point at enrollment)
Total score from the Menopause Rating Scale (MRS), reflecting overall menopausal symptom severity.
1 secondary outcome
Correlation Between TEMPS-A Subscale Scores and MRS Total/Subscale Scores
Time frame: Baseline (single time point at enrollment)
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 18 Nov 2025.
- Derived from this study: PubMed 42091421Hayirlioglu N, Ilhan C. Affective Temperament Traits as Predictors of Menopausal Symptom Severity in the Late Menopausal Transition and Early Postmenopause. J Obstet Gynaecol Res. 2026 May;52(5):e70317. doi: 10.1111/jog.70317.
- Individual participant dataSharing planned: No
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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.
Cemile Ilhan, MD principal investigator
Bagcilar Training and Research Hospital
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 Personality, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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 18 Nov 2025. 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 Turkey (Türkiye). 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?
TEMPS-A Depressive Subscale Score at Baseline (time frame: Baseline (single time point at enrollment)). The study lists 9 primary outcomes in all. 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 NCT06972290, which also lists 1 linked publication.
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 18 Nov 2025.