CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Armodafinildrug
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/NCT01460628
NCT01460628Phase 4Completed
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The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women

Massachusetts General Hospital·interventional·Posted Oct 27, 2011·Updated Mar 15, 2017

In Brief

A Phase 4 clinical trial evaluating Armodafinil for Menopause. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if armodafinil improves quality of life and is an effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause
CountriesUnited States
CollaboratorsTeva Pharmaceuticals USA

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago

Interventions

Armodafinildrug

Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.