Progesterone vs Placebo Therapy for Women With Epilepsy

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.

Conditions

• Epilepsy

Interventions

BIOLOGICAL

Progesterone Lozenges

200mg Progesterone Lozenges

OTHER

Matched Placebo Lozenges

Matched Placebo Lozenges

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Emory University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Montreal Neurological Institute and Hospital

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Minnesota Comprehensive Epilepsy Program

  collaborator UNKNOWN

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Andrew G Herzog, M.D., M.Sc. · Beth Israel Deaconess Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-10-31

Primary Completion

2010-06-30

Completion

2010-06-30

Countries

• United States
• Canada

Study Locations