Clinical trial
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
Name
11-11/11.2021
Description
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.
Trial arms
Trial start
2021-12-01
Estimated PCD
2023-03-01
Trial end
2023-03-01
Status
Completed
Phase
Early phase I
Treatment
oral menopausal hormone therapy
Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg
Arms:
Oral MHT, Transdermal MHT
transdermal menopausal hormone therapy
Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg
Arms:
Oral MHT, Transdermal MHT
Size
40
Primary endpoint
Evaluation of the severity of menopausal syndrome
3 months
Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)
3 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-06-22
1 organization
2 products
1 indication
Indication
Late Menstrual Period