CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 294 enrolled
Drug / intervention
Progesterone Lozenges +1 morebiological
Likely dose
Progesterone 200 mg lozengesAI-extracted
Key inclusion· 5
  • ✓Age 13–45 years
  • ✓Documented seizure history by EEG
  • ✓At least 2 seizures or auras per month in the past 3 months
  • ✓Stable antiepileptic drug therapy for at least 2 months
Key exclusion· 4
  • ✕Pregnant or lactating
  • ✕On major tranquilizers, antidepressant medications, or reproductive hormones
  • ✕Unable to document seizures
  • ✕Progressive neurological or systemic disorder, or >2-fold elevation in liver enzyme levels

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

Search/NCT00029536
NCT00029536Phase 3Completed
CompareCT.gov

Phase 3 Study of Progesterone vs Placebo Therapy

Beth Israel Deaconess Medical Center·interventional·Posted Jan 16, 2002·Updated Jun 5, 2017

In Brief

A Phase 3 clinical trial evaluating Progesterone Lozenges and Matched Placebo Lozenges for Epilepsy. Completed, enrolled 294 participants across 15 sites in 2 countries.

Detailed Summary

The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesCanada, United States
CollaboratorsBrigham and Women's Hospital, Columbia University, Dartmouth-Hitchcock Medical Center, Emory University, Johns Hopkins University, Montreal Neurological Institute and Hospital, Ohio State University, Thomas Jefferson University, University of Maryland, University of Southern California, University of Virginia, Weill Medical College of Cornell University, Minnesota Comprehensive Epilepsy Program

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2002
Enrollment StartOct 1, 2000
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 24.5 years ago

Interventions

Progesterone Lozengesbiological

200mg Progesterone Lozenges

Matched Placebo Lozengesother

Matched Placebo Lozenges