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Epilepsy Birth Control Registry (EBCR)

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.
 
ClinicalTrials.gov Identifier: NCT01097837
Recruitment Status : Unknown
Verified October 2015 by Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C..
Recruitment status was:  Recruiting
First Posted : April 2, 2010
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.

Study Description
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Brief Summary:

Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.

Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest information about birth control for women with epilepsy.


Condition or disease Intervention/treatment
Epilepsy Other: Non-interventional

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Epilepsy Birth Control Registry
Study Start Date : March 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Epilepsy
Cohort is comprised of women with epilepsy between 18 and 47.
 Other: Non-interventional
This is an observational study conducted by anonymous survey. There is no intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are women with epilepsy between the ages of 18 and 47.
Criteria

Inclusion Criteria:

  • Women with Epilepsy between 18 and 47

Exclusion Criteria:

  • Women without epilepsy
  • Women under 18
  • Women over 47
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097837


Contacts
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Contact: Kristen M Fowler, MA 781-431-0277 kfowler@bidmc.harvard.edu

Locations
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United States, Massachusetts
Neuroendocrine Associates P.C. Recruiting
Wellesley, Massachusetts, United States, 02481
Contact: Kristen M Fowler, MA    781-431-0277    kfowler@bidmc.harvard.edu   
Principal Investigator: Andrew G Herzog, M.D.,M.Sc.         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States
Contact: Kristen M Fowler, MA    781-431-0277    kfowler@bidmc.harvard.edu   
Principal Investigator: Anne R Davis, M.D.,M.P.H.         
Principal Investigator: W Allen Hauser, M.D.         
Sponsors and Collaborators
Neuroendocrine Associates P.C.
Columbia University
Investigators
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Principal Investigator: Andrew G Herzog, M.D.,M.Sc. Neuroendocrine Associates P.C.
More Information
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Responsible Party: Andrew G. Herzog M.D., M.Sc., Principal Investigator, Neuroendocrine Associates P.C.
ClinicalTrials.gov Identifier: NCT01097837    
Other Study ID Numbers: 137557
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.:
Epilepsy
Contraceptive
Birth Control
Seizure
This study is looking at the use of different birth control measures in women with epilepsy.
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases