Epilepsy Birth Control Registry (EBCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Neuroendocrine Associates P.C.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.
ClinicalTrials.gov Identifier:
NCT01097837
First received: March 31, 2010
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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 Intervention
Epilepsy
Other: Non-interventional

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Epilepsy Birth Control Registry

Resource links provided by NLM:


Further study details as provided by Neuroendocrine Associates P.C.:

Primary Outcome Measures:
  • Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: March 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097837

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

Locations
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
Principal Investigator: Andrew G Herzog, M.D.,M.Sc. Neuroendocrine Associates P.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Andrew G. Herzog M.D., M.Sc., Principal Investigator, Neuroendocrine Associates P.C.
ClinicalTrials.gov Identifier: NCT01097837     History of Changes
Other Study ID Numbers: 137557
Study First Received: March 31, 2010
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014