Hormone Therapy on Serum Ischemia Modified Albumin in 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).

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Key information

Conditions

Hormone Therapy Induced Morphologic Change Surgical Menopause

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jun 9, 2020
Registry last updated: Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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