Hot FlashesNCT05892211
LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
An observational study of Hot Flashes and Sleep, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center. The sympathetic overactivation during the hot flashes is associated with awakening during sleep and have a negative impact on cardiac indexes… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Sleep, Menopause
- What is being tested?
- Polysomnography, Skin conductance and ALU and LINE-1 DNA methylation analysis
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 8 Mar 2032
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consists of women aged between 45-55 with low cardiovascular disease risk profile assessed by Framingham score system. The study population doesn't include any women who were already diagnosed with hypertension, coronary heart disease, diabetes, obstructive sleep apnea and stroke. It is a very homogenous population in terms of baseline cardiovascular disease risk apart from the presence or absence of hot flashes.
Who may be able to join
- 45-55 years of age
- Women with serum FSH levels >35 IU/L, serum estradiol levels <20 pg/mL
- Women with low cardiovascular disease risk profile (Framingham score for coronary heart disease <10%),
- Low high sensitive CRP levels (<5 mg/L),
- Fasting glucose <90 mg/dL,
- Fasting levels of insulin <37.06 µIU/mL,
Show all 9Show fewer
- Blood pressure <140/90 mmHg (measured 2 times with 10 minutes interval),
- TSH <4.2 mIU/L and fT4 <1.7 ng/dL,
- Hemoglobin levels 12-16 g/dL, leucocyte count <10.3*10^3/µL and neutrophil count <4.9*10^3/µL; eosinophil count <0.5*10^3/µL, basophil count <0.2*10^3/µL
Who cannot join
- Women with high cardiovascular disease risk profile (Framingham score for coronary heart disease >10%),
- Women who were diagnosed with a cardiovascular disease (coronary heart disease, stroke),
- Women with hypertension,
- Smokers,
- BMI >30 kg/m2,
- Women with diabetes
Show all 10Show fewer
- Women who were surgically postmenopausal,
- Women who used hormone therapy in the last three months,
- Women with obstructive sleep apnea
- Women who are using medicine which may cause sleep disturbances.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: The Pilot Study of LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center. The sympathetic overactivation during the hot flashes is associated with awakening during sleep and have a negative impact on cardiac indexes and vascular reactivity. Therefore, hot flashes are accepted as subclinical cardiovascular risk factor.
The association between the severity of the hot flashes and cardiovascular risk may have an epigenetic background. Recently, methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk (atherosclerosis and hypertension etc.). A transposable element in the DNA, Long interspersed nuclear elements (LINE-1), was found to be hypomethylated in cases with ischemic heart disease and stroke. Therefore, the expression of repeating elements in the DNA (LINE-1 and ALU) may be considered as a mediator in the ischemic heart disease. Until now, menopausal age, vasomotor symptoms and epigenetic and biological aging have been evaluated. However, the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated. In this study, we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women with vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1.
Read the detailed description
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center. The variations in the range of thermoneutral zone determine the severity of the vasomotor symptoms. Sympathetic overactivation during the hot flash and decreased rate of parasympathetic control on the heart rate are the main factors contributing to the cardiovascular disease risk. The hot flashes which occur and cause awakening during sleep have negative impact on cardiac indexes and vascular reactivity. Therefore, vasomotor symptoms are accepted as subclinical cardiovascular risk factor.
Hot flashes associated with nighttime awakenings were shown to increase systolic and diastolic blood pressure and decrease pre-ejection period. Objectively recorded hot flashes and nighttime awakenings were found to be correlated white matter hyperintensities in the brain which show poor brain health. In addition, white matter hyperintensities may be considered as a cerebral small vascular disease and is associated with greater odds of having stroke and dementia.
Among postmenopausal women, cardiovascular disease is the most prevalent cause for mortality and morbidity. It results from the interaction of environmental and genetic factors. The association between the severity of hot flashes and cardiovascular risk may have an epigenetic background. The global DNA methylations were found to be decreased in postmenopausal women with high cardiovascular disease risk. Recently, methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk (atherosclerosis and hypertension etc.). A transposable element in the DNA, Long interspersed nuclear elements (LINE-1), was found to be hypomethylated in cases with ischemic heart disease and stroke. Therefore, the expression of repeating elements in the DNA (LINE-1 and ALU) may be considered a mediator in the ischemic heart disease. Until now, menopausal age, vasomotor symptoms and epigenetic and biological aging have been evaluated. However, the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated. In this study, we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women who have low cardiovascular disease risk profile at baseline and have vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1.
- Conditions
- Hot Flashes, Sleep, Menopause, Cardiovascular Diseases, Epigenetics, DNA Methylation
- Being tested
- Polysomnography, Skin conductance, ALU and LINE-1 DNA methylation analysis, The Menopause-Specific Quality of Life Questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI)
- Keywords
- DNA methylation, Hot Flashes, Sleep, Vasomotor symptoms, Menopause, Cardiovascular Diseases, epigenetics
- Medical subject headings
- Hot Flashes, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Polysomnography is performed by 3-channel electroencephalography ((EEG; F4-M1, C4-M1, O2-M1), 2-channel electrooculography (EOG), chin electromyography (EMG), surface EMG recording from tibialis anterior muscles of the right and left leg, body position, oronasal thermal airflow sensor, nasal pressure sensor, thoracic and abdominal respiratory belts for assesing the respiratory effort, electrocardiography (ECG), pulse, recording of respiratory sounds, oxygen saturation and synchronous video recording. The sleep stages are scored by the current criteria of American Academy of Sleep Medicine.
Skin conductanceDiagnostic test
The sympathetic skin response recordings are performed with a four-channel electromyography apparatus (Nihon-Kohden). They are recorded from both sides of the sternum with the active and reference electrodes placed 2 cm apart from the midline.
ALU and LINE-1 DNA methylation analysisGenetic
2 cc peripheric venous blood is drawn from the participants to the test tubes with EDTA. DNA isolation is done by Nucleospin Blood Kit (REF:740951.250, Macherey-Nagel). Epitect Fast DNA Bisulfite Kit (REF:59824, Qiagen) is used to do DNA bisulfite modification. ALU and LINE-1 site specific methylation primer is designed and the methylation patterns are compared between the groups by Epitect Methylight PCR Kit (Cat. No:59496, Qiagen).
The Menopause-Specific Quality of Life Questionnaire (MENQOL)Diagnostic test
The Menopause-Specific Quality of Life Questionnaire (MENQOL) is filled by each participant to assess the health related quality of life before the polysomnography test.
Pittsburgh Sleep Quality Index (PSQI)Diagnostic test
Pittsburgh Sleep Quality Index (PSQI) is done by each participant to assess the sleep quality and disturbances before thepolysomnography test.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (vasomotor symptoms present) | Participants who have vasomotor symptoms. Sleep is recorded by polysomnography for a night. Hot flashes during sleep are recorded by two electrodes measuring the skin conductance near sternum. Any hot flashes reported subjectively by the patient during the recording is noted. Their blood samples are obtained. Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Skin conductance; Genetic: ALU and LINE-1 DNA methylation analysis; Diagnostic Test: The Menopause-Specific Quality of Life Questionnaire (MENQOL); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI) | |
| Group 2 (vasomotor symptoms absent) | Participants who don't have vasomotor symptoms. Sleep is recorded by polysomnography for a night. Hot flashes during sleep are recorded by two electrodes measuring the skin conductance near sternum. Any hot flashes reported subjectively by the patient during the recording is noted. Their blood samples are obtained. Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Skin conductance; Genetic: ALU and LINE-1 DNA methylation analysis; Diagnostic Test: The Menopause-Specific Quality of Life Questionnaire (MENQOL); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation levels of ALU and LINE-1
Methylation levels of ALU and LINE-1 in women with vasomotor symptoms
Measured: 1 day
Polysomnographic findings
Total sleep time in women with vasomotor symptoms
Measured: 1 night
Number of objective hot flashes per night
Number of objective hot flashes per night measured by sternal skin conductance in women with vasomotor symptoms
Measured: 1 night
Number of nighttime awakenings per night
Number of nighttime awakenings per night associated with hot flash episodes
Measured: 1 night
Polysomnographic findings
Sleep efficiency in women with vasomotor symptoms
Measured: 1 night
Polysomnographic findings
Sleep stages in women with vasomotor symptoms
Measured: 1 night
Secondary outcomes (2)
Subjective sleep findings (Pittsburgh Sleep Quality Index (PSQI))
Scores of PSQI questionnaire in women with vasomotor symptoms (>5 can be considered as a significant sleep disturbance.)
Measured: 1 night
Menopause-Specific Quality of Life Questionnaire (MENQOL) scores and its association with hot flashes per night
Scores of MENQOL and its association with hot flashes per night (There is no limit, higher scores on the MENQOL indicate a poorer quality of life.)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion8 Mar 2032 (estimated)
Why it stopped: The university has relocated to a new place due to earthquake.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Project Coordination Unit of Istanbul University-Cerrahpasa
- Responsible party
- Principal investigator, Ipek B. Ozcivit Erkan, MD, Istanbul University - Cerrahpasa
- Investigators
- Ipek Betul Ozcivit Erkan, MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892211
- Sponsor's protocol ID
- E-83045809-604.01.02-3916
- Status last verified
- Apr 2025
- First submitted
- 9 May 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data could be shared on demand.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Study of LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
- ClinicalTrials.gov ID
- NCT05892211
- Acronym / sponsor ID
- E-83045809-604.01.02-3916
- Conditions
- Hot Flashes, Sleep, Menopause, Cardiovascular Diseases, Epigenetics, DNA Methylation
- Keywords
- DNA methylation, Hot Flashes, Sleep, Vasomotor symptoms, Menopause, Cardiovascular Diseases, epigenetics
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The university has relocated to a new place due to earthquake.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Scientific Research Project Coordination Unit of Istanbul University-Cerrahpasa
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 8 Mar 2032 (estimated)
- First posted
- 7 Jun 2023 (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.
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center. The sympathetic overactivation during the hot flashes is associated with awakening during sleep and have a negative impact on cardiac indexes and vascular reactivity. Therefore, hot flashes are accepted as subclinical cardiovascular risk factor.
The association between the severity of the hot flashes and cardiovascular risk may have an epigenetic background. Recently, methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk (atherosclerosis and hypertension etc.). A transposable element in the DNA, Long interspersed nuclear elements (LINE-1), was found to be hypomethylated in cases with ischemic heart disease and stroke. Therefore, the expression of repeating elements in the DNA (LINE-1 and ALU) may be considered as a mediator in the ischemic heart disease. Until now, menopausal age, vasomotor symptoms and epigenetic and biological aging have been evaluated. However, the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated. In this study, we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women with vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1.
Detailed description
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center. The variations in the range of thermoneutral zone determine the severity of the vasomotor symptoms. Sympathetic overactivation during the hot flash and decreased rate of parasympathetic control on the heart rate are the main factors contributing to the cardiovascular disease risk. The hot flashes which occur and cause awakening during sleep have negative impact on cardiac indexes and vascular reactivity. Therefore, vasomotor symptoms are accepted as subclinical cardiovascular risk factor.
Hot flashes associated with nighttime awakenings were shown to increase systolic and diastolic blood pressure and decrease pre-ejection period. Objectively recorded hot flashes and nighttime awakenings were found to be correlated white matter hyperintensities in the brain which show poor brain health. In addition, white matter hyperintensities may be considered as a cerebral small vascular disease and is associated with greater odds of having stroke and dementia.
Among postmenopausal women, cardiovascular disease is the most prevalent cause for mortality and morbidity. It results from the interaction of environmental and genetic factors. The association between the severity of hot flashes and cardiovascular risk may have an epigenetic background. The global DNA methylations were found to be decreased in postmenopausal women with high cardiovascular disease risk. Recently, methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk (atherosclerosis and hypertension etc.). A transposable element in the DNA, Long interspersed nuclear elements (LINE-1), was found to be hypomethylated in cases with ischemic heart disease and stroke. Therefore, the expression of repeating elements in the DNA (LINE-1 and ALU) may be considered a mediator in the ischemic heart disease. Until now, menopausal age, vasomotor symptoms and epigenetic and biological aging have been evaluated. However, the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated. In this study, we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women who have low cardiovascular disease risk profile at baseline and have vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (vasomotor symptoms present) | – | Diagnostic Test: Polysomnography, Diagnostic Test: Skin conductance, Genetic: ALU and LINE-1 DNA methylation analysis, Diagnostic Test: The Menopause-Specific Quality of Life Questionnaire (MENQOL), Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI)Participants who have vasomotor symptoms. Sleep is recorded by polysomnography for a night. Hot flashes during sleep are recorded by two electrodes measuring the skin conductance near sternum. Any hot flashes reported subjectively by the patient during the recording is noted. Their blood samples are obtained. |
| Group 2 (vasomotor symptoms absent) | – | Diagnostic Test: Polysomnography, Diagnostic Test: Skin conductance, Genetic: ALU and LINE-1 DNA methylation analysis, Diagnostic Test: The Menopause-Specific Quality of Life Questionnaire (MENQOL), Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI)Participants who don't have vasomotor symptoms. Sleep is recorded by polysomnography for a night. Hot flashes during sleep are recorded by two electrodes measuring the skin conductance near sternum. Any hot flashes reported subjectively by the patient during the recording is noted. Their blood samples are obtained. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of women aged between 45-55 with low cardiovascular disease risk profile assessed by Framingham score system. The study population doesn't include any women who were already diagnosed with hypertension, coronary heart disease, diabetes, obstructive sleep apnea and stroke. It is a very homogenous population in terms of baseline cardiovascular disease risk apart from the presence or absence of hot flashes.
Key inclusion criteria (9 listed)
- 45-55 years of age
- Women with serum FSH levels >35 IU/L, serum estradiol levels <20 pg/mL
- Women with low cardiovascular disease risk profile (Framingham score for coronary heart disease <10%),
- Low high sensitive CRP levels (<5 mg/L),
- Fasting glucose <90 mg/dL,
Key exclusion criteria (10 listed)
- Women with high cardiovascular disease risk profile (Framingham score for coronary heart disease >10%),
- Women who were diagnosed with a cardiovascular disease (coronary heart disease, stroke),
- Women with hypertension,
- Smokers,
- BMI >30 kg/m2,
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 |
|---|---|---|
| PolysomnographyPolysomnography is performed by 3-channel electroencephalography ((EEG; F4-M1, C4-M1, O2-M1), 2-channel electrooculography (EOG), chin electromyography (EMG), surface EMG recording from tibialis anterior muscles of the right and left leg, body position, oronasal thermal airflow sensor, nasal pressure sensor, thoracic and abdominal respiratory belts for assesing the respiratory effort, electrocardiography (ECG), pulse, recording of respiratory sounds, oxygen saturation and synchronous video recording. The sleep stages are scored by the current criteria of American Academy of Sleep Medicine. | Diagnostic test | Group 1 (vasomotor symptoms present), Group 2 (vasomotor symptoms absent) |
| Skin conductanceThe sympathetic skin response recordings are performed with a four-channel electromyography apparatus (Nihon-Kohden). They are recorded from both sides of the sternum with the active and reference electrodes placed 2 cm apart from the midline. | Diagnostic test | Group 1 (vasomotor symptoms present), Group 2 (vasomotor symptoms absent) |
| ALU and LINE-1 DNA methylation analysis2 cc peripheric venous blood is drawn from the participants to the test tubes with EDTA. DNA isolation is done by Nucleospin Blood Kit (REF:740951.250, Macherey-Nagel). Epitect Fast DNA Bisulfite Kit (REF:59824, Qiagen) is used to do DNA bisulfite modification. ALU and LINE-1 site specific methylation primer is designed and the methylation patterns are compared between the groups by Epitect Methylight PCR Kit (Cat. No:59496, Qiagen). | Genetic | Group 1 (vasomotor symptoms present), Group 2 (vasomotor symptoms absent) |
| The Menopause-Specific Quality of Life Questionnaire (MENQOL)The Menopause-Specific Quality of Life Questionnaire (MENQOL) is filled by each participant to assess the health related quality of life before the polysomnography test. | Diagnostic test | Group 1 (vasomotor symptoms present), Group 2 (vasomotor symptoms absent) |
| Pittsburgh Sleep Quality Index (PSQI)Pittsburgh Sleep Quality Index (PSQI) is done by each participant to assess the sleep quality and disturbances before thepolysomnography test. | Diagnostic test | Group 1 (vasomotor symptoms present), Group 2 (vasomotor symptoms absent) |
Primary outcome
Methylation levels of ALU and LINE-1
Time frame: 1 day
Methylation levels of ALU and LINE-1 in women with vasomotor symptoms
Polysomnographic findings
Time frame: 1 night
Total sleep time in women with vasomotor symptoms
Number of objective hot flashes per night
Time frame: 1 night
Number of objective hot flashes per night measured by sternal skin conductance in women with vasomotor symptoms
Number of nighttime awakenings per night
Time frame: 1 night
Number of nighttime awakenings per night associated with hot flash episodes
Polysomnographic findings
Time frame: 1 night
Sleep efficiency in women with vasomotor symptoms
Polysomnographic findings
Time frame: 1 night
Sleep stages in women with vasomotor symptoms
2 secondary outcomes
Subjective sleep findings (Pittsburgh Sleep Quality Index (PSQI))
Time frame: 1 night
Menopause-Specific Quality of Life Questionnaire (MENQOL) scores and its association with hot flashes per night
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided. The data could be shared on demand.
Related trials for Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
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.
Ipek Betul Ozcivit Erkan, MD principal investigator
Istanbul University - Cerrahpasa
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 Hot Flashes and Sleep, run by Istanbul University - Cerrahpasa 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 9 inclusion and 10 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: paused, as of the sponsor's last update on 2 May 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?
Results are not available in the source record.
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?
Methylation levels of ALU and LINE-1 (time frame: 1 day). The study lists 6 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 2 May 2025.