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CompletedNCT04624386Updated Dec 2, 2020

Evaluating Oxidative Stress in Menopause

An observational study in Menopause and Oxidative Stress, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-02.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
77
Ages
30 Years to 75 Years
Sex
Female
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Study summary

Thiol disulfide levels will be determined using venous blood samples from pre- and postmenopausal women to evaluate oxidative stress in menopause. Furthermore, oxidative stress will be assessed according to age, and years since the start of menopause. Also, whether the presence of menopause related osteoporosis has any association with oxidative stress will be determined.

Read the detailed description

A total of 77 subjects are divided into two groups: study group (postmenopausal women) and control group premenopausal women). Biometric data such as age, bmi, obstetric anamnesis, history of komorbidities, PAP smear results are recorded. Mammography results, dexa scores of post menopausal women are also obtained. Venous blood samples from all subjects are collected. Thiol disulfide levels will be determined from serum samples. Thiol disulfide levels will first be compared between the study and the control group in order to determine the oxidative stress in menopause. In secondary evaluation years of menopause, age, and dexa scores will be included.

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Conditions studied

  • Menopause
  • Oxidative Stress
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In context

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Women within 30-75 years of age were recruited to this study. Premenapusal healthy women who visited the clinic for routine gynecological control were included in the control group. Postmenopausal women older than 45 years of age who entered menopause as a natural process were included in the study group.

A total of 43 subjects were included in the study group and 34 subjects were included in the control group

Inclusion criteria

Women who entered menopause as a natural process Women within the age limits Still menstruating healthy women as control subjects

Exclusion criteria

Exclusion Criteria:

Women who have entered menopause prematurely Women who have entered menopause following a surgery Women with medically induced menopause Women without any autoimmune or chronic inflammatory diseases Women who are taking hormone replacement therapy due to menopausal symptoms Women without any malignant diseases

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Postmenopausal/Study

    Women older than 45 years of age and who have not had any menstruation for the past 12 months are considered as having entered menopause. These women are included in this group.

    Other: Thiol disulfide level

  • Premenopausal/Control

    Healthy women who are still having regular menstruations are included in this group

    Other: Thiol disulfide level

Interventions

  • OtherThiol disulfide level

    Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.

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What researchers measure

Primary outcomes

  1. Evaluating Oxidative Stress in Menopause

    Thiol disulfide stress will be evaluated using serum samples from postmenopausal women and comparing these results with samples obtained from premenopausal women.

    Time frame: 2 months

Secondary outcomes

  1. Evaluating Oxidative Stress According to Years of Menopause

    Thiol disulfide levels will be determined and analysis will be done according to the years of menopause

    Time frame: 2 months

  2. Evaluating Oxidative Stress According to Menopause Related Osteoporosis

    Thiol disulfide levels will be determined and analysis will be done according to the osteoporosis scores evaluated with dxa

    Time frame: 2 months

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Study locations

1 site
  • Sisli Hamidiye Etfal Training and Research Hospital
    Istanbul, 34371, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04624386
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Nura Fitnat Topbas Selcuki (Principal Investigator, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Nov 10, 2020
Start date
Aug 30, 2020
Primary completion
Oct 30, 2020
Completion
Nov 4, 2020
Last update
Dec 2, 2020

Study contacts

Nura Fitnat Topbas Selucki, MD
principal investigator · Sisli Hamidiye Etfal Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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