Last Period Not Earlier Than 6 Months AgoPhase 1NCT05678192

Effect of Menopausal Hormone Therapy on Immune System Parameters

A Phase 1 study testing oral menopausal hormone therapy and transdermal menopausal hormone therapy in people with Last Period Not Earlier Than 6 Months Ago, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 45 to 59 years, women onlyHealthy volunteers can take part
Conditions the study is for: Last Period Not Earlier Than 6 Months Ago
What is being tested?: oral menopausal hormone therapy and transdermal menopausal hormone therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteRussia
Study dates: 1 Dec 2021to 1 Mar 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 59 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Absolute contraindications to MHT:
Bleeding from the genital tract of unknown origin
Breast and endometrial cancer
Acute hepatitis
Acute deep vein thrombosis
Acute thromboembolism

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Moscow, 117997

Other trials in Russia

About this study

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

An additional task is to assess the content of blood sex hormones before the start of therapy and after 3 months.

Read the 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
Being tested: oral menopausal hormone therapy, transdermal menopausal hormone therapy
Keywords: immune status, menopausal hormone therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral menopausal hormone therapyDrug
Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg
transdermal menopausal hormone therapyDrug
Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg

Study groups in NCT05678192
Study group	Role	What they receive
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. Receives: 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 Receives: Drug: oral menopausal hormone therapy; Drug: transdermal menopausal hormone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 months

Secondary outcomes (6)

Evaluation of the effect of therapy on the parameters of the immune status
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%.
Measured: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of B-lymphocytes (CD3-CD19+HLA-DR+) in peripheral blood by flow cytometry in %. Literature reference values: 5,0-19,0%.
Measured: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of NK cells (CD3-CD56+CD16+) by flow cytometry in %. Literature reference values: 4,0-26,0%.
Measured: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of classical monocytes (CD14++CD16-) by flow cytometry in %. Literature reference values: 85,0-90,0%.
Measured: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of non-classical monocytes (CD14+CD16++) by flow cytometry in %. Literature reference values: 5,0-10,0%.
Measured: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of T-helper cells (CD3+CD4+) by flow cytometry in %. Literature reference values: 31,0-61,0%.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20211 Mar 2023

First posted10 Jan 2023
Study start1 Dec 2021
Primary completion1 Mar 2023
Study completion1 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Last Period Not Earlier Than 6 Months AgoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05678192
Sponsor's protocol ID: 11-11/11.2021
Status last verified: Jun 2023
First submitted: 14 Dec 2022
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05678192
Acronym / sponsor ID: 11-11/11.2021
Conditions: Last Period Not Earlier Than 6 Months Ago
Keywords: immune status, menopausal hormone therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of HealthcareOther government
Study start: 1 Dec 2021 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 10 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
Transdermal MHT	Other	Drug: oral menopausal hormone therapy, Drug: transdermal menopausal hormone therapyThe 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.
Oral MHT	Other	Drug: oral menopausal hormone therapy, Drug: transdermal menopausal hormone therapyThe 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

Who may qualify

Ages: 45 to 59 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

Absolute contraindications to MHT:
Obesity;
HIV infection and other congenital and acquired immunodeficiencies;
Systemic connective tissue diseases;
Oncological diseases in history;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral menopausal hormone therapyDydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg	Drug	Oral MHT, Transdermal MHT
transdermal menopausal hormone therapyEstradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg	Drug	Oral MHT, Transdermal MHT

Primary outcome

Evaluation of the severity of menopausal syndrome
Time frame: 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)
Time frame: 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.

6 secondary outcomes

Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina Averyanova, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the severity of menopausal syndrome (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.