Multiple Sclerosis, menopause and hormone replacement therapy

• Conditions: Multiple sclerosis; MedDRA version: 17.1Level: LLTClassification code 10064137Term: Progression of multiple sclerosisSystem Organ Class: 100000004852; MedDRA version: 17.1Level: LLTClassification code 10070425Term: Multiple sclerosis exacerbationSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005129-10-FI
• Lead Sponsor: Irina Elovaara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified