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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT04424173

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
CRP Menopause

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 30, 2008

Outcome Measures

Primary Outcome Measures

Blood was drawn for basal CRP from all patients [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karadeniz Technical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suleyman Guven, professor, Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT04424173

Other Study ID Numbers:

2007/25

First Posted:

Jun 9, 2020

Last Update Posted:

Jun 29, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suleyman Guven, professor, Karadeniz Technical University

CRP

Estradiol

Menopause-Specific Quality of Life questionnaire

Norethindrone Acetate.

Study Results

No Results Posted as of Jun 29, 2020