CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Tissue Selective Estrogen Complex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02710214
NCT02710214Phase 2Completed
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Effect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial.

University of California, San Francisco·interventional·Posted Mar 16, 2016·Updated Jul 15, 2020

In Brief

A Phase 2 clinical trial evaluating Tissue Selective Estrogen Complex and Placebo for Menopause and Multiple Sclerosis. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Multiple Sclerosis
CountriesUnited States
CollaboratorsNational Multiple Sclerosis Society

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartFeb 1, 2016
Primary CompletionApr 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.3 years ago

Interventions

Tissue Selective Estrogen Complexdrug

Once-daily dosing of Duavee for 8 weeks.

Placebodrug

Once-daily dosing of placebo for 8 weeks