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A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis

NCT02710214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-15

Study results available
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Summary

Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo controlled pilot study, is to determine whether this medication alleviates menopausal symptoms in women with MS. The investigators will secondarily determine whether addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening inflammation.

Conditions

Interventions

DRUG

Tissue Selective Estrogen Complex

Once-daily dosing of Duavee for 8 weeks.

DRUG

Placebo

Once-daily dosing of placebo for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Riley M Bove, MD · Assistant Professor of Clinical Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-04-24
Completion
2019-04-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02710214 on ClinicalTrials.gov