MenopauseNCT07295093
Menopause Age and Anxiety-Depression
An observational study of Menopause and Primary Ovarian Insufficiency (Poi), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Menopause is defined as the permanent cessation of menstrual cycles due to ovarian follicle depletion, typically occurring after age 50, and is associated with decreased estrogen levels. Primary ovarian insufficiency (POI) involves early ovarian dysfunction before age 40, with infertility as a key concern. Read more about this study
- Who is it for?
- Ages 24 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Primary Ovarian Insufficiency (Poi), Anxiety
- What is being tested?
- Beck Anxıety Inventory (BAI) and State-Trait Anxiety Scale (STAI) 1-2
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Sep 2025
- 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 24 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 136 participants were included in the study, of whom 83 were in the menopause group and 53 in the primary ovarian insufficiency group.
Who may be able to join
- Healthy women over 24 years of age who visited our hospital for routine outpatient check-ups, had been diagnosed with menopause, and had no history of psychiatric disorders before menopause.
Who cannot join
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
- Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
Show all 17Show fewer
- Hepatic dysfunctions
- Renal insufficiency
- Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
- Neurologic diseases
- Psychiatric disorders
- Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
- History of any malignancy
- History of exposure to chemotherapeutic agents or radiotherapy
- Individuals with a history of chronic or regular medication use that could cause anxiety or depression symptoms
- Individuals with a personal history of psychiatric disorders
- Individuals with a history of depression in the past 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Not Valid, 06100
About this study
Official title: Association Between Age at Menopause and Levels of Anxiety and Depression
Menopause is defined as the permanent cessation of menstrual cycles due to ovarian follicle depletion, typically occurring after age 50, and is associated with decreased estrogen levels. Primary ovarian insufficiency (POI) involves early ovarian dysfunction before age 40, with infertility as a key concern. Both menopause and POI may contribute to psychological symptoms, including anxiety and depression, influenced by sociodemographic and health factors. While literature reports anxiety in middle-aged women, data on its association with menopausal timing are limited. This study aims to compare women with POI and those undergoing natural menopause after age 40, assessing the relationship between age at menopause, anxiety, and depression, as well as the impact of fertility expectations on psychological well-being in POI patients.
- Conditions
- Menopause, Primary Ovarian Insufficiency (Poi), Anxiety, Depression, Menopausal Depression
- Being tested
- Beck Anxıety Inventory (BAI), State-Trait Anxiety Scale (STAI) 1-2
- Keywords
- Menopause, Primary Ovarian Insufficiency (Poi), Anxiety, depression
- Medical subject headings
- Primary Ovarian Insufficiency, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beck Anxıety Inventory (BAI)Other
Also called State-Trait Anxiety Scale (STAI) 1-2
Beck Anxıety Inventory (BAI) Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.
State-Trait Anxiety Scale (STAI) 1-2Other
State-Trait Anxiety Scale (STAI) 1-2 Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Menopause group | Patients over 40 years of age who have undergone menopause and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints. Receives: Other: Beck Anxıety Inventory (BAI); Other: State-Trait Anxiety Scale (STAI) 1-2 | |
| Primary ovarian insufficiency (POI) group | Patients who experienced menopause before the age of 40 and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints. Receives: Other: Beck Anxıety Inventory (BAI); Other: State-Trait Anxiety Scale (STAI) 1-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxıety Inventory (BAI), Anxiety level
Anxiety severity measured by the Beck Anxiety Inventory (BAI) during routine clinic visit.
Measured: Baseline (single assessment at enrollment during routine clinic visit).
State-Trait Anxiety Scale (STAI) 1-2, Anxiety level
Anxiety severity measured by the State-Trait Anxiety Inventory (STAI) forms 1 and 2 during routine clinic visit.
Measured: Baseline (single assessment at enrollment during routine clinic visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Dec 2024
- Primary completion5 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
- Investigators
- Merve Didem Eşkin Tanrıverdi, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295093
- Sponsor's protocol ID
- TABED 1-25-1981
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are available which may be shared in necessary conditions.
Publications
Bromberger JT, Meyer PM, Kravitz HM, Sommer B, Cordal A, Powell L, Ganz PA, Sutton-Tyrrell K. Psychologic distress and natural menopause: a multiethnic community study. Am J Public Health. 2001 Sep;91(9):1435-42. doi: 10.2105/ajph.91.9.1435.
PubMed 11527777Zollner YF, Acquadro C, Schaefer M. Literature review of instruments to assess health-related quality of life during and after menopause. Qual Life Res. 2005 Mar;14(2):309-27. doi: 10.1007/s11136-004-0688-z.
PubMed 15892422Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767Bryant C, Judd FK, Hickey M. Anxiety during the menopausal transition: a systematic review. J Affect Disord. 2012 Jul;139(2):141-8. doi: 10.1016/j.jad.2011.06.055. Epub 2011 Jul 23.
PubMed 21783260Grigolon RB, Ceolin G, Deng Y, Bambokian A, Koning E, Fabe J, Lima M, Gerchman F, Soares CN, Brietzke E, Gomes FA. Effects of nutritional interventions on the severity of depressive and anxiety symptoms of women in the menopausal transition and menopause: a systematic review, meta-analysis, and meta-regression. Menopause. 2023 Jan 1;30(1):95-107. doi: 10.1097/GME.0000000000002098. Epub 2022 Nov 7.
PubMed 36576445
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Age at Menopause and Levels of Anxiety and Depression
- ClinicalTrials.gov ID
- NCT07295093
- Acronym / sponsor ID
- TABED 1-25-1981
- Conditions
- Menopause, Primary Ovarian Insufficiency (Poi), Anxiety, Depression, Menopausal Depression
- Keywords
- Menopause, Primary Ovarian Insufficiency (Poi), Anxiety, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 19 Dec 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.
Menopause is defined as the permanent cessation of menstrual cycles due to ovarian follicle depletion, typically occurring after age 50, and is associated with decreased estrogen levels. Primary ovarian insufficiency (POI) involves early ovarian dysfunction before age 40, with infertility as a key concern. Both menopause and POI may contribute to psychological symptoms, including anxiety and depression, influenced by sociodemographic and health factors. While literature reports anxiety in middle-aged women, data on its association with menopausal timing are limited. This study aims to compare women with POI and those undergoing natural menopause after age 40, assessing the relationship between age at menopause, anxiety, and depression, as well as the impact of fertility expectations on psychological well-being in POI patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menopause group | – | Other: Beck Anxıety Inventory (BAI), Other: State-Trait Anxiety Scale (STAI) 1-2Patients over 40 years of age who have undergone menopause and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints. |
| Primary ovarian insufficiency (POI) group | – | Other: Beck Anxıety Inventory (BAI), Other: State-Trait Anxiety Scale (STAI) 1-2Patients who experienced menopause before the age of 40 and who visited our hospital's obstetrics and gynecology outpatient clinic for routine check-ups, without any additional diseases or complaints. |
Who may qualify
- Ages
- 24 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 136 participants were included in the study, of whom 83 were in the menopause group and 53 in the primary ovarian insufficiency group.
Key inclusion criteria (1 listed)
- Healthy women over 24 years of age who visited our hospital for routine outpatient check-ups, had been diagnosed with menopause, and had no history of psychiatric disorders before menopause.
Key exclusion criteria (17 listed)
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
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 |
|---|---|---|
| Beck Anxıety Inventory (BAI)Also: State-Trait Anxiety Scale (STAI) 1-2Beck Anxıety Inventory (BAI) Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit. | Other | Menopause group, Primary ovarian insufficiency (POI) group |
| State-Trait Anxiety Scale (STAI) 1-2State-Trait Anxiety Scale (STAI) 1-2 Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit. | Other | Menopause group, Primary ovarian insufficiency (POI) group |
Primary outcome
Beck Anxıety Inventory (BAI), Anxiety level
Time frame: Baseline (single assessment at enrollment during routine clinic visit).
Anxiety severity measured by the Beck Anxiety Inventory (BAI) during routine clinic visit.
State-Trait Anxiety Scale (STAI) 1-2, Anxiety level
Time frame: Baseline (single assessment at enrollment during routine clinic visit).
Anxiety severity measured by the State-Trait Anxiety Inventory (STAI) forms 1 and 2 during routine clinic visit.
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 19 Dec 2025.
- Background: PubMed 11527777Bromberger JT, Meyer PM, Kravitz HM, Sommer B, Cordal A, Powell L, Ganz PA, Sutton-Tyrrell K. Psychologic distress and natural menopause: a multiethnic community study. Am J Public Health. 2001 Sep;91(9):1435-42. doi: 10.2105/ajph.91.9.1435.
- Background: PubMed 15892422Zollner YF, Acquadro C, Schaefer M. Literature review of instruments to assess health-related quality of life during and after menopause. Qual Life Res. 2005 Mar;14(2):309-27. doi: 10.1007/s11136-004-0688-z.
- Background: PubMed 22588767Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
- Background: PubMed 21783260Bryant C, Judd FK, Hickey M. Anxiety during the menopausal transition: a systematic review. J Affect Disord. 2012 Jul;139(2):141-8. doi: 10.1016/j.jad.2011.06.055. Epub 2011 Jul 23.
- Background: PubMed 36576445Grigolon RB, Ceolin G, Deng Y, Bambokian A, Koning E, Fabe J, Lima M, Gerchman F, Soares CN, Brietzke E, Gomes FA. Effects of nutritional interventions on the severity of depressive and anxiety symptoms of women in the menopausal transition and menopause: a systematic review, meta-analysis, and meta-regression. Menopause. 2023 Jan 1;30(1):95-107. doi: 10.1097/GME.0000000000002098. Epub 2022 Nov 7.
- Individual participant dataSharing planned: No. IPD are available which may be shared in necessary conditions.
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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.
Merve Didem Eşkin Tanrıverdi principal investigator
Ankara City Hospital Bilkent
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 Primary Ovarian Insufficiency (Poi), run by Ankara City Hospital Bilkent 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 1 inclusion and 17 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 19 Dec 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?
Beck Anxıety Inventory (BAI), Anxiety level (time frame: Baseline (single assessment at enrollment during routine clinic visit).). The study lists 2 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 NCT07295093, which also lists 5 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 19 Dec 2025.