Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women

Surgical Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424108
• Other study ID #: 2009/54
• Status: Completed
• Start date: July 1, 2009
• Est. completion date: May 20, 2010

Study information

• Verified date: June 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2010
• Est. primary completion date: May 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hormone Therapy Induced Morphologic Change
• Ischemia
• Surgical Menopause

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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