Last Period Not Earlier Than 6 Months Ago
Conditions
Keywords
immune status, menopausal hormone therapy
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.
Interventions
DRUGoral menopausal hormone therapy
Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg
DRUGtransdermal menopausal hormone therapy
Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg
Sponsors
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effect of therapy on the parameters of the immune status | 3 months | 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%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Сhanges in the level of sex hormones against the background of MHT | 3 months | 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. |
| Assessing satisfaction with MHT using the Menopause symptoms treatment Satisfaction Questionnaire | 3 months | 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. |
Countries
Russia
Outcome results
None listed