Clinical trial NCT05678192: Effect of Menopausal Hormone Therapy on Immune System Parameters
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Last Period Not Earlier Than 6 Months Ago
Keywords: immune status
menopausal hormone therapy
Lead sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Sponsor class: OTHER_GOV
First posted: 2023-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Evaluation of the severity of menopausal syndrome
timeFrame: 3 months
measure: Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
measure: Evaluation of the effect of therapy on the parameters of the immune status
timeFrame: 3 months
Other outcomes:
measure: Сhanges in the level of sex hormones against the background of MHT
timeFrame: 3 months
measure: Сhanges in the level of sex hormones against the background of MHT
timeFrame: 3 months
measure: Сhanges in the level of sex hormones against the background of MHT
timeFrame: 3 months
measure: Assessing satisfaction with MHT using the Menopause symptoms treatment Satisfaction Questionnaire
timeFrame: 3 months
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Study officials:
affiliation: FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
name: Marina Averyanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: