Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women

NCT04424108 | Completed

• 1 other identifier: 2009/54
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Hormone Therapy Induced Morphologic Change; Surgical Menopause

Keywords

IMA; menopause; hormone therapy; cardiovascular risk

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: The treatment of menopause and hormone happens only in female sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 20, 2010
• Last Updated: June 9, 2020

Record last verified: 2020-06