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

NCT01466114 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-11-06

No results posted yet for this study

Summary

Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.

Conditions

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

Interventions

DRUG

estriol

4 capsules of 2 mg (total of 8 mg) PO QD

OTHER

Placebo

4 capsules PO QD

DRUG

Norethindrone

Starting at month 6, and at Months 9 and 12: subjects who are on estriol (Group A) take 0.7 mg PO QD for 2 weeks.

OTHER

Progestin Placebo

Starting at Month 6 and at Months 9 and 12: subjects who are on placebo (Group B) take a second progestin placebo pill PO QD for 2 weeks.

Sponsors & Collaborators

Principal Investigators

  • Rhonda Voskuhl, M.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2021-12-31
Completion
2022-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01466114 on ClinicalTrials.gov