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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.

Tracking Information
First Submitted Date March 31, 2010
First Posted Date April 2, 2010
Last Update Posted Date October 16, 2015
Study Start Date March 2010
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2013)
Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category [ Time Frame: 3 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epilepsy Birth Control Registry
Official Title Epilepsy Birth Control Registry
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants are women with epilepsy between the ages of 18 and 47.
Condition Epilepsy
Intervention Other: Non-interventional
This is an observational study conducted by anonymous survey. There is no intervention.
Study Groups/Cohorts Epilepsy
Cohort is comprised of women with epilepsy between 18 and 47.
Intervention: Other: Non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 1, 2013)
1000
Original Estimated Enrollment
 (submitted: April 1, 2010)
100
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women with Epilepsy between 18 and 47

Exclusion Criteria:

  • Women without epilepsy
  • Women under 18
  • Women over 47
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 47 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01097837
Other Study ID Numbers 137557
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.
Study Sponsor Neuroendocrine Associates P.C.
Collaborators Columbia University
Investigators
Principal Investigator: Andrew G Herzog, M.D.,M.Sc. Neuroendocrine Associates P.C.
PRS Account Neuroendocrine Associates P.C.
Verification Date October 2015