Comparative Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Estradiol / Dydrogesterone in Perimenopausal Women

NCT05156814 | Unknown Phase 4

• 1 other identifier: ESDYC001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To obtain new data allowing personalizing continuous hormonal therapy in perimenopausal women in Russia, the following clinical study is going to be conducted in the Russian Federation:

Conditions

Perimenopausal Disorder; Hot Flashes

Keywords

hot flashes; Estradiol; Dydrogesterone; Cimicifuga racemosa; Perimenopausal Women

Outcome Measures

Primary Outcomes (1)

• Changes in the average number of "hot flashes" per day* as percentages according to data from the patient diary after 84 days (3 cycles) since the initiation of treatment compared to baseline (Visit 0).

  84 days

Secondary Outcomes (11)

• The change in the total score on the Greene Climacteric Scale at the end of the therapy (364 days) compared to baseline.

  364 days

• The frequency of "hot flashes" after 84 days since the initiation of treatment.

  84 days

• Changes in the intensity of of menopausal symptoms calculated using the Menopause Rating Scale (MRS) after 84, 168, and 364 days since the treatment initiation compared to baseline (Visit 0).

  84 days, 168 days, 364 days

• Changes according to the Greene Climacteric Scale in each of the 4 subscales after 84, 168, and 364 days since the initiation of treatment compared to baseline (Visit 0).

  84 days, 168 days, 364 days

• Changes according to the "Hot Flush" Related Daily Interference Scale (HFRDIS) after 84, 168, and 364 days since the initiation of treatment compared to baseline (Visit 0).

  84 days, 168 days, 364 days

Study Arms (3)

Fixed-dose Combination (FDC) estradiol / dydrogesterone

EXPERIMENTAL

Femoston® 1 (1 mg estradiol / 10 mg dydrogesterone), Femoston® 2 (2 mg estradiol / 10 mg dydrogesterone)

Drug: Femoston® 1, Femoston® 2

Combination therapy with estradiol and dydrogesterone

ACTIVE COMPARATOR

Duphaston®, 10 mg and Divigel, 0.1%

Drug: Duphaston; Drug: Divigel

non-hormonal therapy

ACTIVE COMPARATOR

Cimicifuga racemosa rhizomatum extract (Klimadynon®)

Drug: Klimadynon

Interventions

Femoston® 1, Femoston® 2 DRUG

Femoston® 1 (1 mg estradiol / 10 mg dydrogesterone), Femoston® 2 (2 mg estradiol / 10 mg dydrogesterone)

Fixed-dose Combination (FDC) estradiol / dydrogesterone

Duphaston DRUG

Duphaston®, 10 mg

Combination therapy with estradiol and dydrogesterone

Klimadynon DRUG

Cimicifuga racemosa rhizomatum extract

non-hormonal therapy

Divigel DRUG

Divigel, 0.1%

Combination therapy with estradiol and dydrogesterone

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian women in perimenopause (STRAW -1/ +1a) with an intact uterus.
• Age from 40 to 55 years old as of the time of screening.
• Absence of natural menstruations within 4 months, but not longer than for 12 months.
• or more episodes of "hot flashes" in the last 7 days according to the patient diary (at the screening).
• Patients scoring more than 12 points on the Greene Scale.
• Follicle-Stimulating Hormone (FSH) levels more than 25 IU/L, estradiol levels less than 190 pmol/L.
• Consent to the use of barrier methods of contraception.
• Body mass index \<30 kg / m2.
• Signed Informed Consent Form.
• Absence of clinically significant deviations according to the results of medical examination: physical examination (including assessment of the state of the mammary glands), measurement of indicators of vital body functions (blood pressure, heart rate, respiratory rate and body temperature) and gynecological examination.
• The patient's consent to perform all research procedures and adhere to all restrictions provided for by the research protocol.

You may not qualify if:

• Smoking.
• Administration of drugs from the prohibited therapy list.
• Known hypersensitivity to estradiol, dydrogesterone, to the active component of the drug Klimadynon® (dry extract of rhizomes of cimicifuga racemose) or to any of the excipients of the study drugs.
• Pregnancy and breastfeeding.
• Abnormal uterine bleeding from the vagina of unclear etiology within 12 months before the screening stage.
• Breast cancer (diagnosed, suspected, or past).
• Estrogen-dependent malignancies of the sex organs, including endometrial cancer (diagnosed, suspected, or past).
• Known or suspected progestogen-dependent neoplasms (e.g. meningioma).
• Untreated endometrial hyperplasia.
• Venous and arterial thrombosis/thromboembolism, currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic or hemorrhagic stroke; angina pectoris, transient ischemic attack).
• Diagnosed hereditary or acquired predisposition to arterial or venous thrombosis/thromboembolism (eg, hyperhomocysteinemia, deficiency of protein C, protein S or antithrombin III, the presence of antiphospholipid antibodies).
• Acute or chronic liver disease in history (in case of deviation from a norm of liver function indicators); benign and malignant liver tumors (including hemangioma, adenoma, liver cancer) or an increase in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) activity detected during screening by more than 1.5 times relative to the upper limit of normal.
• Porphyria.
• Epilepsy.
• Brain disorders and traumas.

Sponsors & Collaborators

• Scientific Research Institute of Public Health, Russian Federation: lead

Study Sites (1)

Federal State Budget Institution "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov"

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

Dydrogesterone; Klimadynon; Estradiol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Tatiana Semykina

CONTACT

+79219565085; ts@publichealthinstitute.org

Olga Sias

CONTACT

+7 916 211 8811; lek@publichealthinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: November 29, 2021
• Primary Completion: September 1, 2022
• Study Completion: May 1, 2023
• Last Updated: January 6, 2022

Record last verified: 2021-12

Locations

RU (1)