- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07295093
Menopause Age and Anxiety-Depression
December 16, 2025 updated by: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
136
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Not Valid
-
Ankara, Not Valid, Turkey (Türkiye), 06100
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Beck Anxıety Inventory (BAI) Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.
Other Names:
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.
|
|
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.
|
Beck Anxıety Inventory (BAI) Description: The scale will be self-administered and completed by the patient during the routine outpatient clinic visit.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (single assessment at enrollment 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.
|
Baseline (single assessment at enrollment during routine clinic visit).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Julian 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.
- Zollner 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.
- 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.
- Bryant 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.
- Grigolon 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2024
Primary Completion (Actual)
August 5, 2025
Study Completion (Actual)
September 15, 2025
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 16, 2025
First Posted (Actual)
December 19, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 16, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Mental Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Behavioral Symptoms
- Genital Diseases, Female
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Behavior
- Anxiety Disorders
- Depression
- Primary Ovarian Insufficiency
Other Study ID Numbers
- TABED 1-25-1981
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD are available which may be shared in necessary conditions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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