Progesterone vs Placebo Therapy for Women With Epilepsy

Phase 3

Completed

Interventions: Other: Matched Placebo Lozenges
Biological: Progesterone Lozenges

Brief 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.

Detailed Description: This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Catamenial Epilepsy: Placebo Lozenges	Matched Placebo Lozenges	Subjects with catamenial epilepsy received matched placebo lozenges
Catamenial Epilepsy: Progesterone Lozenges	Progesterone Lozenges	Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Noncatamenial Epilespy:Progesterone Lozenges	Progesterone Lozenges	Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Noncatamenial Epilespy: Placebo Lozenges	Matched Placebo Lozenges	Subjects without catamenial epilepsy received matched placebo lozenges

Primary Outcome Measures

Name	Time	Method
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency	9 years	Percent of women who show a greater than 50% decline in average daily seizure frequency

Secondary Outcome Measures

Name	Time	Method
Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately	9 years	Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately
Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.	9 years	Percent of women who show a \>50% decline in average daily seizure frequency for the most severe seizure type.
Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.	9 years	Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.	9 years

Locations (15): Dartmouth-Hitchcock Medical Center
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Lebanon, New Hampshire, United States
University of Virginia
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Charlottesville, Virginia, United States
Columbia Medical Center
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New York, New York, United States
Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
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Philadelphia, Pennsylvania, United States
Montreal Neurological Institute
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Montreal, Quebec, Canada
Ohio State University
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Columbus, Ohio, United States
University of Maryland
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Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
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Baltimore, Maryland, United States
Brigham and Women's Hospital
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Boston, Massachusetts, United States
Emory University School of Medicine
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Atlanta, Georgia, United States
University of Southern California, Keck School of Medicine
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Los Angeles, California, United States
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
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Boston, Massachusetts, United States
Henry Ford Hospital
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Detroit, Michigan, United States
MINCEP Epilepsy Care
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Minneapolis, Minnesota, United States
New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
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New York, New York, United States