Effect of Menopausal Hormone Therapy on Immune System Parameters

Phase 1

Completed

• Conditions: Last Period Not Earlier Than 6 Months Ago
• Interventions: Drug: oral menopausal hormone therapy; Drug: transdermal menopausal hormone therapy

• Registration Number: NCT05678192
• Lead Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

1. 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

2. Obesity;

3. HIV infection and other congenital and acquired immunodeficiencies;

4. Systemic connective tissue diseases;

5. Oncological diseases in history;

6. History of chemotherapy and/or radiation therapy;

7. Autoimmune diseases;

8. Acute diseases and exacerbation of chronic diseases during the last 3 months;

9. Reception of immunomodulatory drugs during the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral MHT	transdermal menopausal hormone therapy	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
Transdermal MHT	oral menopausal hormone therapy	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.
Oral MHT	oral menopausal hormone therapy	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
Transdermal MHT	transdermal menopausal hormone therapy	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.

Primary Outcome Measures

Name	Time	Method
Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)	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.
Evaluation of the severity of menopausal syndrome	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of therapy on the parameters of the immune status	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%.

Trial Locations

Locations (1)

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare; 🇷🇺 Moscow, Russian Federation