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

Menopause Clinical Trial

Official title:

The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424173
• Other study ID #: 2007/25
• Status: Completed
• Start date: August 1, 2007
• Est. completion date: August 30, 2008

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 30, 2008
• Est. primary completion date: August 1, 2008
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• CRP
• 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	Blood was drawn for basal CRP from all patients	The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate	12 months