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Completed

NCT Number: NCT04424173

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

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).

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Key information

Conditions

CRP Menopause

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood was drawn for basal CRP from all patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 9, 2020
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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