NCT00151801 is a Phase 2 clinical trial of estroprogestins in Multiple Sclerosis, sponsored by S. Andrea Hospital.

Who is sponsoring NCT00151801?

NCT00151801 is sponsored by S. Andrea Hospital.

What drugs are being tested in NCT00151801?

Interventions in NCT00151801: estroprogestins, interferon-beta 1a.

What condition does NCT00151801 study?

NCT00151801 studies Multiple Sclerosis.

Is NCT00151801 still recruiting?

NCT00151801 is currently status unknown. Last updated 8 September 2005.

Last reviewed 2005-09-08 · How we verify

NCT00151801

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Status unknown Phase 2 Last updated 8 September 2005

What this trial tests

Phase 2 trial testing estroprogestins in Multiple Sclerosis in 200 participants. Status unknown.

Timeline

1 May 2002

1 December 2008

Quick facts

Lead sponsor	S. Andrea Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 May 2002
Estimated completion	1 December 2008
Sites	1 location across Italy

Drugs / interventions tested

estroprogestins — full drug profile →
interferon-beta 1a

Conditions studied

Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

S. Andrea Hospital

Who can join

Adults 18 to 40, female only, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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,

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Estrogen treatment in multiple sclerosis.
Gold SM, Voskuhl RR. · · 2009 · cited 74× · PMID 19539954 · DOI 10.1016/j.jns.2009.05.028
Oral contraceptives combined with interferon β in multiple sclerosis.
Pozzilli C, De Giglio L, Barletta VT, Marinelli F, et al · · 2015 · cited 55× · PMID 26140279 · DOI 10.1212/nxi.0000000000000120
Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial.
De Giglio L, Marinelli F, Barletta VT, Pagano VA, et al · · 2017 · cited 27× · PMID 27995531 · DOI 10.1007/s40263-016-0401-0
Remyelination in animal models of multiple sclerosis: finding the elusive grail of regeneration.
Packer D, Fresenko EE, Harrington EP. · · 2023 · cited 10× · PMID 37448959 · DOI 10.3389/fnmol.2023.1207007

Verify or expand the search:

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other S. Andrea Hospital trials

Trials by the same sponsor.

NCT07391137 — CRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC · NA · active not recruiting
NCT03660917 — Riluzole in Patients With Spinocerebellar Ataxia Type 7 · Phase 2, PHASE3 · recruiting
NCT04327323 — CCM Italian Registry · unknown
NCT03888924 — Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00151801 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by S. Andrea Hospital
Last refreshed: 8 September 2005

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00151801.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing