Epilepsy Birth Control Registry (EBCR)

• ClinicalTrials.gov Identifier: NCT01097837
• Recruitment Status: Unknown
• First Posted: April 2, 2010
• Last Update Posted: October 16, 2015
• Sponsor: Neuroendocrine Associates P.C.
• 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
• 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

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

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