Hormone Therapy Induced Morphologic ChangeNCT04424108
Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women
An observational study of Hormone Therapy Induced Morphologic Change and Surgical Menopause, run by Karadeniz Technical University.
Trial summary
Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Therapy Induced Morphologic Change, Surgical Menopause
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2009to 20 May 2010
- How long will I take part?
- 12 Months
- 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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Within 10 months of the study period, estradiol hemihydrate for all patients who underwent TAH + BSO for gynecology and obstetrics in our clinic and evaluated with the diagnosis of surgical menopause in the postoperative period (6th week) was prescribed. These cases were evaluated in terms of inclusion and exclusion criteria after they were determined to be volunteers to participate in the study.
Who may be able to join
- accepting consent to participate in the trial and signing the form
- Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)
- Presence of vasomotor or menopausal symptoms (moderate to severe);
- no systemic disease or infectious disease in the past 2 weeks
- Not taking any other hormone therapy or medication until postoperative 6th week;
- no contraindications for hormone therapy in routine menopause evaluation;
- Willingness to take hormone therapy
- No smoking.
Who cannot join
- Any systemic disease presence
- Smoking
- Contraindications for hormone therapy
- Failure to follow-up
- Inability to complete three months of hormone therapy
- quitting hormone therapy for other medical reasons during hormone therapy
- Cases reported as preinvasive and invasive genital tumors as a result of TAH + BSO
- Cases reported as suspicious findings in the mammography report
About this study
Official title: The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women
Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. Until the last 10 years, based on the results of observational studies, postmenopausal HT may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. However, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of HT.
The aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. The serum İMA levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).
- Keywords
- IMA, menopause, hormone therapy, cardiovascular risk
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring serum ischemia-modified albumin (IMA) level
After collecting all blood, serums were re-dissolved, and serum IMA levels were checked. IMA level was evaluated by the rapid colorimetric method developed by Barr-Or as an absorbance unit. For IMA, the results were recorded in the spectrophotometer at appropriate wavelengths, and the results were recorded as absorbance units.
Measured: 12 months
Hormone therapy usage
Estradiol hemihydrate containing preparation 12 boxes in all patients given 1 tablet per day (2 mg / day) was prescribed as. Patients were recommended to reapply at the 3rd, 6th, and 12th months of treatment following drug use.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2009
- Primary completion1 May 2010
- Study completion20 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Therapy Induced Morphologic ChangeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424108
- Sponsor's protocol ID
- 2009/54
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women
- ClinicalTrials.gov ID
- NCT04424108
- Acronym / sponsor ID
- 2009/54
- Keywords
- IMA, menopause, hormone therapy, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 1 May 2010 (actual)
- Study completion
- 20 May 2010 (actual)
- First posted
- 9 Jun 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.
Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. Until the last 10 years, based on the results of observational studies, postmenopausal HT may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. However, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of HT.
The aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. The serum İMA levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Within 10 months of the study period, estradiol hemihydrate for all patients who underwent TAH + BSO for gynecology and obstetrics in our clinic and evaluated with the diagnosis of surgical menopause in the postoperative period (6th week) was prescribed. These cases were evaluated in terms of inclusion and exclusion criteria after they were determined to be volunteers to participate in the study.
Key inclusion criteria (8 listed)
- accepting consent to participate in the trial and signing the form
- Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)
- Presence of vasomotor or menopausal symptoms (moderate to severe);
- no systemic disease or infectious disease in the past 2 weeks
- Not taking any other hormone therapy or medication until postoperative 6th week;
Key exclusion criteria (8 listed)
- Any systemic disease presence
- Smoking
- Contraindications for hormone therapy
- Failure to follow-up
- Inability to complete three months of hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring serum ischemia-modified albumin (IMA) level
Time frame: 12 months
After collecting all blood, serums were re-dissolved, and serum IMA levels were checked. IMA level was evaluated by the rapid colorimetric method developed by Barr-Or as an absorbance unit. For IMA, the results were recorded in the spectrophotometer at appropriate wavelengths, and the results were recorded as absorbance units.
Hormone therapy usage
Time frame: 12 months
Estradiol hemihydrate containing preparation 12 boxes in all patients given 1 tablet per day (2 mg / day) was prescribed as. Patients were recommended to reapply at the 3rd, 6th, and 12th months of treatment following drug use.
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 9 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Therapy Induced Morphologic Change and Surgical Menopause, run by Karadeniz Technical University.
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 8 inclusion and 8 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Measuring serum ischemia-modified albumin (IMA) level (time frame: 12 months). 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?
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 9 Jun 2020.