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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by S. Andrea Hospital.
Recruitment status was:  Recruiting
Information provided by:
S. Andrea Hospital Identifier:
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

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.

Condition Intervention Phase
Multiple Sclerosis
Drug: estroprogestins
Drug: interferon-beta 1a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by S. Andrea Hospital:

Primary Outcome Measures:
  • Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
  • Relapse rate at 6, 12, 18 and 24 months,
  • EDSS progression at 12 and 24 months,
  • MS functional composite score at 12 and 24 months,

Secondary Outcome Measures:
  • Number and volume of new gad-enhancing lesions at 12 and 24 months
  • Number of new T1 and T2 lesions at 12 and 24 months
  • Brain volume changes at 12 and 24 months
  • Neuropsychological examination at 0, 12, 24 months
  • Hamilton scale for depression score at 0, 12, 24 months
  • MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months
  • Fatigue Severity Scale score at 0, 12, 24 months

Estimated Enrollment: 200
Study Start Date: May 2002
Estimated Study Completion Date: December 2008
Detailed Description:

Phase 2, randomised, single blind, three arms study.

Follow-up of 24 months.

The study will include relapsing-remitting multiple sclerosis female patients.

Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).

Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.

A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24.

MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle).

During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients
  • Clinically definite relapsing-remitting MS according to the McDonald criteria
  • Age between 18-40 y.o.
  • EDSS from 0 to 4.0, inclusive

Exclusion Criteria:

  • History of migraine or thromboembolic events
  • Reproductive system disorders
  • Pregnancy or suspension of pregnancy within 12 months prior to randomisation
  • Prior use of estroprogestins within the last 3 months prior to randomisation
  • Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
  • Prior use of immunomodulating drugs within the last 6 months prior to randomisation
  • Prior use of corticosteroids within the last 3 months prior to randomisation
  • Have clinical relapse 30 days prior to randomisation
  Contacts and Locations
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Please refer to this study by its identifier: NCT00151801

Department of Neurology - University of Rome La Sapienza
Rome, Italy, 00100
Sponsors and Collaborators
S. Andrea Hospital
Study Chair: Valentina Tomassini, MD Department of Neurological Science University of Rome "La Sapienza"
Principal Investigator: Fabiana Marinelli, MD Department of Neurological Science, University of Rome "La Sapienza"
Study Director: Carlo Pozzilli, MD Department of Neurological Science, University of Rome "La Sapienza"
  More Information


Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00151801     History of Changes
Other Study ID Numbers: NEU - PIL - 03 
Study First Received: September 8, 2005
Last Updated: September 8, 2005

Keywords provided by S. Andrea Hospital:
multiple sclerosis
sex hormones

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Ethinyl Estradiol
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on February 20, 2017