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Completed

NCT Number: NCT05678192

Effect of Menopausal Hormone Therapy on Immune System Parameters

The objective of the study is to evaluate the effect of menopausal hormone therapy on the parameters of the immune system. To do this, patients took blood to assess the immune status before the start of therapy and after 3 months.

An additional task is to assess the content of blood sex hormones before the start of therapy and after 3 months.

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Key information

Conditions

Last Period Not Earlier Than 6 Months Ago

Age range

45 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Moscow, 117997, Russia

About this study

A study of 60 perimenopausal and postmenopausal patients was included. The cohort was divided into groups depending on the treatment regimen.

Group 1 (n=20) received transdermal menopausal hormone therapy (MHT). Group 2 (n=20) received oral MHT.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age from 45 to 59;
  • phase of reproductive aging - perimenopause, postmenopause or surgical menopause (ovariectomy);
  • indications for prescribing MHT

Exclusion criteria

  • Absolute contraindications to MHT:
  • Bleeding from the genital tract of unknown origin
  • Breast and endometrial cancer
  • Acute hepatitis
  • Acute deep vein thrombosis
  • Acute thromboembolism
  • Cutaneous porphyria
  • Obesity;
  • HIV infection and other congenital and acquired immunodeficiencies;
  • Systemic connective tissue diseases;
  • Oncological diseases in history;
  • History of chemotherapy and/or radiation therapy;
  • Autoimmune diseases;
  • Acute diseases and exacerbation of chronic diseases during the last 3 months;
  • Reception of immunomodulatory drugs during the last 3 months.

Treatment and study plan

oral menopausal hormone therapy

Drug

Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg

transdermal menopausal hormone therapy

Drug

Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg

Primary outcomes

  1. Evaluation of the severity of menopausal syndrome

    Time frame: 3 months

    The Green scale questionnaire was used initially and after 3 months against the background of menopausal hormone therapy. The questionnaire includes 21 questions from 0 to 3 points, where a lower score means a better result.

  2. Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)

    Time frame: 3 months

    The WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF) was used at baseline and 3 months later. The questionnaire includes 26 questions, from 1 to 5 points, where a higher score means a better result.

Secondary outcomes

  1. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: the content cytotoxic T-lymphocytes (CD3+CD8+) in peripheral blood by flow cytometry in %. Literature reference values: 14,0-36,0%.

  2. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: content of B-lymphocytes (CD3-CD19+HLA-DR+) in peripheral blood by flow cytometry in %. Literature reference values: 5,0-19,0%.

  3. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: content of NK cells (CD3-CD56+CD16+) by flow cytometry in %. Literature reference values: 4,0-26,0%.

  4. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: content of classical monocytes (CD14++CD16-) by flow cytometry in %. Literature reference values: 85,0-90,0%.

  5. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: content of non-classical monocytes (CD14+CD16++) by flow cytometry in %. Literature reference values: 5,0-10,0%.

  6. Evaluation of the effect of therapy on the parameters of the immune status

    Time frame: 3 months

    Determination of blood parameters of immune status: content of T-helper cells (CD3+CD4+) by flow cytometry in %. Literature reference values: 31,0-61,0%.

Other outcomes

  1. Сhanges in the level of sex hormones against the background of MHT

    Time frame: 3 months

    Assessment of changes in the level of sex hormone in peripheral blood: follicle-stimulating hormone (IU/l). Reference values: 2.0-10.0 IU/l. Blood sampling is performed at baseline and after 3 months.

  2. Сhanges in the level of sex hormones against the background of MHT

    Time frame: 3 months

    Assessment of changes in the level of sex hormone in peripheral blood: estradiol (pmol/l). Reference values: 150 - 450 pmol/l. Blood sampling is performed at baseline and after 3 months.

  3. Сhanges in the level of sex hormones against the background of MHT

    Time frame: 3 months

    Assessment of changes in the level of sex hormone in peripheral blood: testosterone (nmol/l). Reference values: 0,52 - 2,5 nmol/l. Blood sampling is performed at baseline and after 3 months.

  4. Assessing satisfaction with MHT using the Menopause symptoms treatment Satisfaction Questionnaire

    Time frame: 3 months

    The Menopause symptoms treatment Satisfaction Questionnaire is used after 3 months of MHT. The questionnaire includes 8 questions from 1 to 5 points from a very satisfactory result to a completely unsatisfactory one.

Sponsors and collaborators

Lead sponsor

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Other Gov

Registry information

Official study title

Optimization of Management Tactics for Postmenopausal Patients in Need of Menopausal Hormone Therapy, Taking Into Account the Effect on the Parameters of the Immune System

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Jun 22, 2023

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.