Effect of Menopausal Hormone Therapy on Immune System Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Last Period Not Earlier Than 6 Months Ago
• Intervention / Treatment: Drug: oral menopausal hormone therapy; Drug: transdermal menopausal hormone therapy

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Transdermal MHT; 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; Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg; Drug: transdermal menopausal hormone therapy; Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg
Other: Oral MHT; 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; Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg; Drug: transdermal menopausal hormone therapy; Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Сhanges in the level of sex hormones against the background of MHT	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.	3 months
Сhanges in the level of sex hormones against the background of MHT	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 months
Сhanges in the level of sex hormones against the background of MHT	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.	3 months
Assessing satisfaction with MHT using the Menopause symptoms treatment Satisfaction Questionnaire	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.	3 months

Collaborators and Investigators

• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
• Investigators: Principal Investigator: Marina Averyanova, PhD, FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: immune status; menopausal hormone therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 11-11/11.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No