Effect of Menopausal Hormone Therapy on Immune System Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Last Period Not Earlier Than 6 Months Ago

Intervention / Treatment
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* Drug: oral menopausal hormone therapy
* Drug: transdermal menopausal hormone therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transdermal MHT<br>The group includes women 45-59 years old, with menopausal symptoms. The choice of transdermal MHT was based on personal history (chronic diseases of the gastrointestinal tract, high blood pressure, etc.), family history (stroke, thromboembolism in relatives, etc.), and patient preferences. Used estradiol hemihydrate 0.6 mg 2 protective pumps. The progesterone component of MHT includes micronized progesterone 100 mg or 200 mg, depending on the MHT regimen (continuous or cyclic). Blood sampling to determine the immune status is carried out before the start of therapy after 3 months. | Drug: oral menopausal hormone therapy<br>* Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg<br>Drug: transdermal menopausal hormone therapy<br>* Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg<br>|
| Other: Oral MHT<br>The group includes women 45-59 years old, with menopausal symptoms. Examination before the appointment of MHT can be carried out according to clinical recommendations. The choice of transdermal MHT was based on the history (chronic diseases of the gastrointestinal tract, high blood pressure, etc.), family history (stroke, thromboembolism in relatives, etc.), the patient's preferences.Drugs used in this group include: Dydrogesterone 5 mg + Estradiol 1 mg or Dydrogesterone 10 mg + Estradiol 1 mg, depending on the MHT regimen. Blood sampling to determine the immune status is performed before the start of therapy and after 3 months | Drug: oral menopausal hormone therapy<br>* Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg<br>Drug: transdermal menopausal hormone therapy<br>* Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the severity of menopausal syndrome | 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. | 3 months | 
| Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF) | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of therapy on the parameters of the immune status | 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%. | 3 months | 
| Evaluation of the effect of therapy on the parameters of the immune status | 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 months | 
| Evaluation of the effect of therapy on the parameters of the immune status | 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%. | 3 months | 
| Evaluation of the effect of therapy on the parameters of the immune status | Determination of blood parameters of immune status: content of classical monocytes (CD14++CD16-) by flow cytometry in %. Literature reference values: 85,0-90,0%. | 3 months | 
| Evaluation of the effect of therapy on the parameters of the immune status | 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%. | 3 months | 
| Evaluation of the effect of therapy on the parameters of the immune status | 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%. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune status, menopausal hormone therapy