Effect of Menopausal Hormone Therapy on Immune System Parameters

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

Status and phase: Completed; Phase 1

Conditions: Last Period Not Earlier Than 6 Months Ago

Treatments: Drug: transdermal menopausal hormone therapy; Drug: oral menopausal hormone therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05678192

11-11/11.2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 45 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Transdermal MHT

Other group

Description:

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.

Treatment:

Drug: oral menopausal hormone therapy

Drug: transdermal menopausal hormone therapy

Oral MHT

Other group

Description:

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

Treatment:

Drug: oral menopausal hormone therapy

Drug: transdermal menopausal hormone therapy