Clinical TrialID 2429

Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition

NCT01466114

Relapsing-remitting Multiple Sclerosis|Secondary-progressive Multiple Sclerosis|Primary-progressive Multiple Sclerosis

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
2429
Evidence Id
2429
Core Evidence Id
2429
Source Clinical Trial Id
2406
Herb2 Clinical Trial Id
HBCT002406
Nct Id
NCT01466114
Title
Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
Status
Phase
Phase 2
Study Result
No
Study Condition
Relapsing-remitting Multiple Sclerosis|Secondary-progressive Multiple Sclerosis|Primary-progressive Multiple Sclerosis
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: estriol|OTHER: Placebo|DRUG: Norethindrone|OTHER: Progestin Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
Female
Age
Adult
Enrollment
64
Outcome Measure
Change from baseline in cognitive function assessed by Paced Serial Addition Test (PASAT)., Processing speed will be assessed by PASAT. Numerical test scores (ranging from 0-60) will be acquired, then percent change for each subject at trial conclusion as compared to baseline will be determined. Whether greater improvement as expressed as percent change occurs in the estriol group as compared to the placebo group will be determined., 1 year
Sponsor Collaborator
University of California, Los Angeles
Funded By
OTHER
Location
University of California Los Angeles, Los Angeles, California, 90095, United States|The University of Colorado Denver, Aurora, Colorado, 80045, United States|The University of New Mexico, Albuquerque, New Mexico, 87131, United States|The University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Other Id
11-002055
Start Date
2011-10
Primary Completion Date
2021-12
Completion Date
2022-04
First Posted
2011-11-06
Results First Posted
Last Update Posted
2019-11-06
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01466114
Title Cn
Title En
Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
Bilingual Status
semi_complete