Effect of Menopausal Hormone Therapy on Immune System Parameters

NCT ID: NCT05678192

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-03-01

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.

Conditions

Last Period Not Earlier Than 6 Months Ago

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

oral menopausal hormone therapy

Intervention Type: DRUG

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

transdermal menopausal hormone therapy

Intervention Type: DRUG

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

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

Group Type: OTHER

oral menopausal hormone therapy

Intervention Type: DRUG

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

transdermal menopausal hormone therapy

Intervention Type: DRUG

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

Interventions

oral menopausal hormone therapy

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

Intervention Type: DRUG

transdermal menopausal hormone therapy

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Averyanova, PhD

Role: PRINCIPAL_INVESTIGATOR

FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

11-11/11.2021

Identifier Type: -

Identifier Source: org_study_id