Evaluating Oxidative Stress in Menopause

Menopause Clinical Trial

Official title:

Evaluating Oxidative Stress in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04624386
• Other study ID #: menopausethiol
• Status: Completed
• Start date: August 30, 2020
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 4, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Menopause
• Oxidative Stress

Intervention

Other:
• Thiol 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.

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Secondary	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	2 months
Secondary	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	2 months