Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women

NCT ID: NCT04424173

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-01
• Study Completion Date: 2008-08-30

Brief Summary

This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).

Conditions

CRP; Menopause

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Accepting consent to participate in the research and signing the form;
• Postmenopausal women 45-55 years old
• not having had menstruation for the past 6 months;
• Hormone results compatible with menopause (FSH> 20 milli-International unit(mIU) / mL, E2 <20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe);
• no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks;
• not taking any hormone therapy or medication for at least 2 months;
• no contraindications for hormone therapy in routine menopause evaluation;
• Willingness to take hormone therapy
• No smoking.

Exclusion Criteria

• Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence
• Smoking
• Contraindications for hormone therapy
• Failure to follow-up
• Inability to complete three months of hormone therapy
• Stopping hormone therapy due to vaginal bleeding during hormone therapy

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Suleyman Guven

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2007/25

Identifier Type: -

Identifier Source: org_study_id