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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04424173
Other study ID # 2007/25
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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