Multiple Sclerosis, menopause and hormone replacement therapy

• Register: EUCTR
• Last refreshed on: 2 February 2015
• Main ID: EUCTR2014-005129-10-FI
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: Irina Elovaara
• Public title: Multiple Sclerosis, menopause and hormone replacement therapy
• Scientific title: Multiple Sclerosis and Menopause: the effect of hormone replacement therapy on clinical picture and immunology of multiple sclerosis
• Date of first enrolment: 27/01/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005129-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Healthy control subjects Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: Irina Elovaara
• Affiliation: Irina Elovaara

• Name: Irina Elovaara
• Affiliation: Irina Elovaara

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Intervention(s)

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 type: equal
Concentration number: 2-
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Femoston 1/10
Product Name: Femoston 1/10
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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 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.

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 Outcome(s)

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

Secondary ID(s)

Elovaara09112014

Source(s) of Monetary Support

Tampere University hospital