NCT05678192

Effect of Menopausal Hormone Therapy on Immune System Parameters

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Other Government
• Sex: Female
• Age: 45 Years – 59 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	oral menopausal hormone therapy	Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg
DRUG	transdermal menopausal hormone therapy	Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2023-01-10
• Last updated: 2023-06-22

Locations

1 site across 1 country: Russia