Multiple sclerosis MedDRA version: 17.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852 MedDRA version: 17.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Femoston 2/10
Product Name: Femoston 2/10
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Irina Elovaara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Gender: female - Age 44-54 years - Peri- or postmenopausal - Course of diasease: relapsing-remitting - Multiple sclerosis is diagnosed with valid diagnostic criteria (valid at the time of the diagnosis) - Active disease (relapse or new T2- or Gd+ -lesion in MRI within a year) - EDSS max. 5.5 - No estrogen/progestin or estrogen in use or two months wash-out period - No treatment or interferon beta, glatiramer acetate or teriflunomide for multiple sclerosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Course of disease: primary or secondary progressive multiple sclerosis or clinically isolated syndrome - EDSS more than 5.5 - Use of estrogen/progestin or estrogen without two months wash-out period - Severe other health medical condition (e.g. malignancy, other autoimmune or neurodegenerative disease, severe psycholocigal disease) - Contraindication for hormone replacement therapy - Other immunomodulatory treatment than interferon beta, glatiramere acetate or teriflunomidi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the effect of menopause on clinical picture, physical and cognitive functions and quality of life in female with relapsing-remitting multiple sclerosis.;Secondary Objective: To research the effect of hormone replacement therapy on menopausal symptoms, quality of life, subjective and objective physical and cognitive functions, activity of the disease, immunology and MRI findings in female with multiple sclerosis. ;Primary end point(s): Disease progression: 1 point EDSS progression within a year is considered as a clinically significant change if EDSS in the beginning is 0-3.5. 0,5 point EDSS progression within a year is considered as a clinically significant change if EDSS in the beginning is 4.0-5.5. ;Timepoint(s) of evaluation of this end point: 0 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective cognitive functions: statistically significant difference between the test results in the beginning and in the end ;Timepoint(s) of evaluation of this end point: 0, 3 and 12 months | — |
Countries
Finland
Contacts
Public ContactIrina Elovaara
Irina Elovaara
Outcome results
None listed