Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women

NCT ID: NCT04424108

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-01
• Study Completion Date: 2010-05-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Suleyman Guven

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2009/54

Identifier Type: -

Identifier Source: org_study_id