MenopauseNCT04624386
Evaluating Oxidative Stress in Menopause
An observational study of Menopause and Oxidative Stress, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Oxidative Stress
- What is being tested?
- Thiol disulfide level
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2020to 4 Nov 2020
- 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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Women who entered menopause as a natural process Women within the age limits Still menstruating healthy women as control subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, 34371
About this study
Official title: Evaluating Oxidative Stress in Postmenopausal Women
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.
- Conditions
- Menopause, Oxidative Stress
- Being tested
- Thiol disulfide level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiol disulfide levelOther
Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Thiol disulfide level | |
| Premenopausal/Control | Healthy women who are still having regular menstruations are included in this group Receives: Other: Thiol disulfide level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
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
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Aug 2020
- Primary completion30 Oct 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nura Fitnat Topbas Selcuki, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Nura Fitnat Topbas Selucki, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624386
- Sponsor's protocol ID
- menopausethiol
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Oxidative Stress in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04624386
- Acronym / sponsor ID
- menopausethiol
- Conditions
- Menopause, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 10 Nov 2020 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal/Study | – | Other: Thiol disulfide levelWomen 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. |
| Premenopausal/Control | – | Other: Thiol disulfide levelHealthy women who are still having regular menstruations are included in this group |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Women who entered menopause as a natural process Women within the age limits Still menstruating healthy women as control subjects
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Thiol disulfide levelVenous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood. | Other | Postmenopausal/Study, Premenopausal/Control |
Primary outcome
Evaluating Oxidative Stress in Menopause
Time frame: 2 months
Thiol disulfide stress will be evaluated using serum samples from postmenopausal women and comparing these results with samples obtained from premenopausal women.
2 secondary outcomes
Evaluating Oxidative Stress According to Years of Menopause
Time frame: 2 months
Evaluating Oxidative Stress According to Menopause Related Osteoporosis
Time frame: 2 months
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 2 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Nura Fitnat Topbas Selucki, MD principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
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 Oxidative Stress, run by Sisli Hamidiye Etfal Training and Research Hospital 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 1 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 2 Dec 2020. 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?
Evaluating Oxidative Stress in Menopause (time frame: 2 months). 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 Dec 2020.