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

NCT04424173 | Completed

• 1 other identifier: 2007/25
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Keywords

CRP; Estradiol; Menopause-Specific Quality of Life questionnaire; Norethindrone Acetate.

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: The treatment of menopause and hormone happens only in female sex.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of cases, whose hormone therapy was planned due to menopausal symptoms in the menopause unit of our clinic, were evaluated in terms of admission, and non-acceptance criteria, during the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 30, 2008
• Last Updated: June 29, 2020

Record last verified: 2020-06