We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Progesterone vs Placebo Therapy for Women With Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00029536
First Posted: January 16, 2002
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham 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
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center
January 15, 2002
January 16, 2002
March 31, 2017
June 5, 2017
June 5, 2017
October 2000
June 2010   (Final data collection date for primary outcome measure)
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency [ Time Frame: 9 years ]
Percent of women who show a greater than 50% decline in average daily seizure frequency
Not Provided
Complete list of historical versions of study NCT00029536 on ClinicalTrials.gov Archive Site
  • Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type. [ Time Frame: 9 years ]
    Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.
  • 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 [ Time Frame: 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
  • Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment. [ Time Frame: 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. [ Time Frame: 9 years ]
Not Provided
Not Provided
Not Provided
 
Progesterone vs Placebo Therapy for Women With Epilepsy
Phase 3 Study of Progesterone vs Placebo Therapy
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsy
  • Biological: Progesterone Lozenges
    200mg Progesterone Lozenges
  • Other: Matched Placebo Lozenges
    Matched Placebo Lozenges
  • Experimental: Catamenial Epilepsy: Progesterone Lozenges
    Subjects with catamenial epilepsy received 200 mg progesterone lozenges
    Intervention: Biological: Progesterone Lozenges
  • Placebo Comparator: Catamenial Epilepsy: Placebo Lozenges
    Subjects with catamenial epilepsy received matched placebo lozenges
    Intervention: Other: Matched Placebo Lozenges
  • Experimental: Noncatamenial Epilespy:Progesterone Lozenges
    Subjects without catamenial epilepsy received 200 mg progesterone lozenges
    Intervention: Biological: Progesterone Lozenges
  • Placebo Comparator: Noncatamenial Epilespy: Placebo Lozenges
    Subjects without catamenial epilepsy received matched placebo lozenges
    Intervention: Other: Matched Placebo Lozenges

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
294
June 2010
June 2010   (Final data collection date for primary outcome measure)

INCLUSION:

  1. Subject must be between the ages of 13 and 45.
  2. Subject must have a history of seizures (documented by EEG).
  3. Subject must have had at least 2 seizures or auras per month during the past 3 months.
  4. Subject must be on stable antiepileptic drug therapy for at least 2 months.
  5. Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry.

EXCLUSION:

  1. Subject that is pregnant or lactating.
  2. Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones.
  3. Subject that is unable to document seizures.
  4. Subject that has progressive neurological or systemic disorder or > 2-fold elevation in liver enzyme levels
Sexes Eligible for Study: Female
13 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00029536
2001P001408
NINDS NS39466
CRC
Yes
Not Provided
Not Provided
Andrew Herzog, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • Brigham 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
Principal Investigator: Andrew G Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP