Effect of Menopausal Hormone Therapy on Immune System Parameters

NCT05678192 | Completed Phase 1 DMC

• 1 other identifier: 11-11/11.2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Last Period Not Earlier Than 6 Months Ago

Keywords

immune status; menopausal hormone therapy

Outcome Measures

Primary Outcomes (2)

• Evaluation of the severity of menopausal syndrome

  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.

  3 months

• Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)

  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.

  3 months

Secondary Outcomes (6)

• Evaluation of the effect of therapy on the parameters of the immune status

  3 months

• Evaluation of the effect of therapy on the parameters of the immune status

  3 months

• Evaluation of the effect of therapy on the parameters of the immune status

  3 months

• Evaluation of the effect of therapy on the parameters of the immune status

  3 months

• Evaluation of the effect of therapy on the parameters of the immune status

  3 months

Other Outcomes (4)

• Сhanges in the level of sex hormones against the background of MHT

  3 months

• Сhanges in the level of sex hormones against the background of MHT

  3 months

• Сhanges in the level of sex hormones against the background of MHT

  3 months

Study Arms (2)

Transdermal MHT

OTHER

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.

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

Oral MHT

OTHER

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

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

Interventions

oral menopausal hormone therapy DRUG

Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg

Oral MHT; Transdermal MHT

transdermal menopausal hormone therapy DRUG

Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg

Oral MHT; Transdermal MHT

Eligibility Criteria

• Age: 45 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age from 45 to 59;
• phase of reproductive aging - perimenopause, postmenopause or surgical menopause (ovariectomy);
• indications for prescribing MHT

You may not qualify if:

• 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
• Obesity;
• HIV infection and other congenital and acquired immunodeficiencies;
• Systemic connective tissue diseases;
• Oncological diseases in history;
• History of chemotherapy and/or radiation therapy;
• Autoimmune diseases;
• Acute diseases and exacerbation of chronic diseases during the last 3 months;
• Reception of immunomodulatory drugs during the last 3 months.

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 117997, Russia

Location

MeSH Terms

Interventions

Hormone Replacement Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Marina Averyanova, PhD

  FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 10, 2023
• Study Start: December 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

RU (1)