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Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients

NCT00151801 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2005-09-09

No results posted yet for this study

Summary

Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.

The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.

The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.

Conditions

Interventions

DRUG

estroprogestins

DRUG

interferon-beta 1a

Sponsors & Collaborators

  • S. Andrea Hospital

    lead OTHER

Principal Investigators

  • Valentina Tomassini, MD · Department of Neurological Science University of Rome "La Sapienza"

  • Fabiana Marinelli, MD · Department of Neurological Science, University of Rome "La Sapienza"

  • Carlo Pozzilli, MD · Department of Neurological Science, University of Rome "La Sapienza"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Completion
2008-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00151801 on ClinicalTrials.gov